Evaluation of Phenylephrine Stability in 0.9% Sodium Chloride Polyvinyl Chloride Bags - Juniper Publishers

Pharmacology & Clinical Research - Juniper Publishers

Abstract

Purpose: Phenylephrine hydrochloride (HCl) is a commonly used adjuvant in anesthesia for the treatment of hypotension, as well as, shock and shock-like states. Phenylephrine HCl is manufactured in a highly concentrated form, and therefore must be diluted before use in patients. Phenylephrine HCl is commonly diluted into 100 mL 0.9% normal saline bags, ensuring the dilute form is readily available if an urgent or emergent situation occurs. A 100 mL bag of dilute phenylephrine is likely excessive for one patient, and thus may be used on multiple patients provided the provider ensures proper aseptic technique is utilized. The purpose of this study was to examine the stability of phenylephrine in polyvinyl chloride (PVC) bags. Methods. Phenylephrine HCl 10 mg/mL solution was diluted with 0.9% sodium chloride for injection to a final concentration of 100 μg/mL and stored at room temperature (23°C - 25°C) exposed to fluorescent light, room temperature (23°C - 25°C) exposed to dark, 4°C exposed to dark, and 52°C exposed to dark. Stability of phenylephrine HCl was evaluated by high-performance liquid chromatography (HPLC) on days 0, 15, 30, and 138. Results. Phenylephrine HCl diluted to 100 μg/mL with 0.9% sodium chloride injection was physically stable throughout the study, except when it was exposed to fluorescent light. Phenylephrine HCl retained ≥ 90% of the original concentration when it remained in the dark at 4°C, room temperature, and 52°C. However, Phenylephrine HCl degraded by >35% when it was exposed to normal fluorescent light at room temperature. When exposed to fluorescent light, phenylephrine HCl discolored over time and developed a slightly turbid appearance. Conclusions. Phenylephrine HCl diluted to a concentration of 100 μg/mL in 0.9% sodium chloride was stable for at least 138 days with ≤10% degradation when stored in PVC bags in the dark at 4°C, room temperature (23°C - 25°C), and 52°C. Phenylephrine HCl diluted to a concentration of 100 μg/mL in 0.9% sodium chloride was not stable when exposed to fluorescent lighting at room temperature.

Keywords:Phenylephrine Hydrochloride; Fluorescent Light; Vasoconstriction; Fluorescent Lighting; Anesthesiologists; Paroxysmal Supraventricular Tachycardia

Abbreviations:FDA: Food and Drug Administration; HCL: Hydrochloride; PVC: Polyvinyl Chloride; HPLC: High-Performance Liquid Chromatography; IV: Intravenous; PVC: Polyvinyl Chloride

Introduction

Chemical stability of pharmaceutical molecules is an important physicochemical property as it affects the safety and efficacy of drug products. The Food and Drug Administration (FDA) states that there is a regulatory requirement of stability testing data to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors [1-4]. Information regarding the stability of a drug helps in determining the required formulation and storage conditions to maintain efficacy and safety measures as well as the desired shelf life. Drug products are known to be affected by a variety of environmental factors such as temperature, humidity and light as well as product related factors such as chemical and physical properties of active substance and of pharmaceutical excipient, the dosage form and its composition, the manufacturing process, the nature of the container closure system and properties of packaging material [5-6]. Thus, the stability study is essential not only for regulatory approval but also ensures safety of the patient. Phenylephrine hydrochloride (HCl) is a synthetic sympathomimetic agent similar to epinephrine and ephedrine [7]. Its potent alpha-1-adrenergic-agonist properties lead to vasoconstriction and increased perfusion pressure. For this reason phenylephrine is commonly used by anesthesiologists to increase blood pressure during surgical procedures [8-11]. In addition to the maintenance of an adequate level of blood pressure, it is used for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia [12].

Phenylephrine can be administered as an intravenous (IV) bolus dose or a continuous IV infusion. To prepare phenylephrine for administration, concentrated stock phenylephrine vials must be further diluted. Pharmacies commonly prepare phenylephrine hydrochloride 100 μg/mL syringes for use by anesthesiologists. Parenteral products in solution form need to be tested to ensure its purity, safety and accuracy when used in a clinical setting as storage conditions may impact pH, temperature, light and oxidation which are the critical factors for drug product degradation [13,14]. Previous stability studies have shown phenylephrine to be stable for up to 30 days at room temperature when diluted to 100 μg/mL in sodium chloride 0.9% in polyvinyl chloride (PVC) bags, and up to 60 days when diluted to 200 and 400 μg/mL [15, 16]. However, no studies have evaluated the stability of phenylephrine stored in PVC bags for as long as 138 days. The purpose of this study was to determine the physical and chemical stability of phenylephrine diluted to 100 μg/mL in 0.9% sodium chloride PVC bags when stored using four different conditions. The first condition was at room temperature (23°C - 25°C) in a dark drawer (RT dark), while exposed to minimal amounts of fluorescent lighting. The second condition was room temperature (23°C - 25°C), exposed to constant ambient light, including fluorescent lighting (RT light). The third and fourth conditions were stored in the dark at 4°C and 52°C respectively, while exposed to minimal amounts of fluorescent lighting. Stability of the diluted phenylephrine solutions was evaluated over a 138-day period.

Methods

Sample Preparation

Dilution of phenylephrine hydrochloride to 100 μg/mL was performed under aseptic technique by adding 10 mg of phenylephrine to 100 mL 0.9% sodium chloride PVC bags. The bags were then stored at their respective storing conditions: 52°C water bath, room temperature (23°C - 25°C) exposed to direct fluorescent light, room temperature (23°C - 25°C) with no light, and refrigerated at 4°C. Four different bags corresponding to different storage conditions were assessed for physical and chemical stability over a total period of 138 days. Stabilities were assessed on a short-term (days 0, 15, 30) and long-term (day 138) basis (Figure 1).

Physical Evaluation

Physical stability of phenylephrine was assessed by visual examination. Solutions were evaluated against a black and white background for visible particulate matter, cloudiness, or color change. The pH of the samples was not assessed, as previous studies have not demonstrated appreciable changes in pH. Phenylephrine concentrations were determined using highperformance liquid chromatography (HPLC) with ultraviolet light. The HPLC system consisted of an autosampler, a delivery pump, a C18 column with a guard column, a variable-wavelength ultraviolet light detector set at 273 nm, a data integrator, and a solvent waste container. A gradient mobile phase system consisting of 0.02M ammonium acetate with 0.1% formic acid (A) and methanol with 0.1% formic acid (B) was used. The separation was achieved with a linear gradient program as follows: 20% v/v B at zero time; from 0 to 5 min, ramp up to 67% v/v B; from 5.01 to 20 min, hold 20% v/v B. The flow rate was 1.5 mL/min. The injection volume was 100 μL. The chromatograms were extracted at 273 nm. All determinations were performed at 25°C. The HPLC software, Chem Station (Version C.01.09; Agilent, 2018) was used to perform the regression analysis, generate the best-fit equations, and generate the coefficient of correlation values. Chromatogram peak heights and areas were used to determine phenylephrine concentrations. All samples for each storage condition were assayed in duplicate. Calibration of the HPLC system was performed by construction of a standard curve using nine known concentrations of phenylephrine hydrochloride (range, 3.125– 200 μg/mL) (Figures 2-10). Coefficients of determination (R2) for the standard curve were 0.995–0.999 for the entire study. Retention time for phenylephrine was on average around 3-4 minutes. Phenylephrine diluted to 100 μg/mL in 0.9% sodium chloride for injection was physically stable in all conditions except for room temperature (23°C - 25°C) exposed to fluorescent light. When exposed to light at room temperature, the solutions changed from clear to a light red hue color with a slightly turbid appearance around day 108. Approximately, on average 7.6% to 10.0% phenylephrine degradation was observed over the 138- day study in all conditions except the room temperature exposed to fluorescent light which experienced a 36.5% degradation (Table 1).

Study Limitations

The study was originally designed to determine long-term stability at Day 120. However, we encountered a technical problem whereby the HPLC column experienced catastrophic failure after day 30. Several attempts to repair the column were performed including extended wash cycles and regeneration cycles. These attempts were unsuccessful and had to resort to ordering a duplicate HPLC column with the same characteristics as the original one. The duplicate HPLC column had to undergo several quality control tests to ensure reliability prior to using it for this experiment. Consequently, the duplicate HPLC column was verified to be operational on day 137 and therefore the longterm stability testing date was performed on the following day (day 138) (Figure 11 & 12).

Discussion

Previous studies have evaluated the stability of phenylephrine in 0.9% sodium chloride solution [14-16]. A study by Gupta [14] found that phenylephrine was stable in 0.9% sodium chloride solution for 14 days. This study found less than 1% degradation of phenylephrine stored in PVC bags using HPLC analysis after the 14-day period [14]. While the Gupta [14] study showed almost no degradation (<1%) of phenylephrine exposed to light, the current study revealed a 4.07% degradation of phenylephrine exposed to light at 15 days. The Kiser [15] study found that phenylephrine remained stable for 30 days while exposed to normal fluorescent lighting. All samples involved in the Kiser study experienced less than 2% degradation over the 30-day study period [15]. Despite a slightly higher degradation rate of 2.2% to 6.4% at the 30-day point, the current study also showed stability of phenylephrine in solution at 30-days. A 60-day study by Jensen [16] demonstrated the stability of phenylephrine to continue over the course of the study. The Jensen study showed a 1% to 3% degradation at 30 days, and about 4% to 6% degradation at 60 days [16]. The current study suggests that phenylephrine remains stable in solution for at least 138 days when stored in the dark. Similar to previous studies it also suggests that phenylephrine remains stable for at least 60 days when a room temperature sample is exposed to normal fluorescent lighting. This study did not look at the sterility of phenylephrine in solution. Phenylephrine manufacturers do not include preservatives within the phenylephrine vials, and the sterility of prepared solutions of phenylephrine must be assessed according to the standards in chapter 797 of the United States Pharmacopeia [17]. Further research is needed to assess the sterility of phenylephrine solutions for long-term use. Knowledge of the extended stability and storage conditions of phenylephrine in solution in PVC bags allows individual practitioners and pharmacies to prepare solutions in advance and store them until the drug is clinically needed. This allows immediate access and reduced delivery time to a potentially life-saving drug in the event of a hypotensive emergency. Additionally, the extended stability of phenylephrine in solution could potentially reduce drug costs and wastage over time.

Conclusion

This study suggests that phenylephrine hydrochloride diluted to a concentration of 100 μg/mL in 0.9% sodium chloride remains stable for at least 138 days for samples that are stored in the dark. Similar to previous studies this study also suggests that phenylephrine hydrochloride diluted to a concentration of 100 μg/mL in 0.9% sodium chloride exposed to normal fluorescent lighting is stable for at least 60 days at room temperature.

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An Antenatal Diagnostic of Meckel Gruber Syndrome (MKS): Case Report - Juniper Publishers

 Reproductive Medicine - Juniper Publishers

Abstract

MKS, Meckel Gruber syndrome is a rare, lethal, genetic multiple congenital anomaly characterized by the following triad: cerebral malformation (primarily occipital encephalocele), polycystic kidneys, and polydactyly, as well as associated abnormalities that may include cleft lip/palate, cardiac and genital abnormalities, central nervous system (CNS) malformations, hepatic fibrosis, and bone dysplasia.

The mode of transmission of MKS is autosomal recessive. Genetic counseling should be offered to couples at risk. MKS is lethal in utero or in the very early neonatal period, with pulmonary hypoplasia and renal failure being the main causes of early death. Our case illustrates the importance of prenatal diagnosis, essentially by ultrasound, in order to ensure adequate management.

Keywords: Meckel syndrome; Renal dysplasia; Encephalocele; Antenatal diagnosis; Polydactyly

Abbreviations: CNS: Central Nervous System; AR: Autosomal Recessive; MKS: Meckel-Gruber Syndrome

Introduction

Meckel-Gruber Syndrome, is a rare, lethal, autosomal recessive congenital polymalformative syndrome, which was first described in 1822 in the German literature [1]. MKS was described by Meckel in 1822, and Gruber in 1934 combining encephalocele, cystic dysplasia of the kidneys, and polydactyly. The variability of the clinical cases reported in the literature demonstrates that the multifaceted nature of this syndrome is an essential characteristic. Ultrasound is, at present, the best means of antenatal diagnosis of this lethal poly malformation [2]. The diagnosis is based mainly on the genetic study especially karyotype, thus allowing to separate the differential diagnosis especially trisomy and 13,18, as it also allows to assign the genetic counseling to the couple. In this article we report a case of Meckel-Gruber syndrome in a young couple with notion of consanguinity, who benefited from an echography within the framework of screenings of malformation making suspect this syndrome before the encephalocele and polycystic kidneys, the pregnancy stopped at 28 weeks of amenorrhea.

Case Presentation

We hereby present the case of a 20-year-old woman, without any particular pathological history, primigravida primiparous, with notion of 1st degree consanguinitis, the patient was followed at our facility and underwent a first-trimester ultrasound examination at 14 weeks of gestation, showing occipital encephalocele (Figure A), hydrocephalus, renal dysplasia and non-visualized bladder (Figure B), raising strong suspicion of MKS syndrome. The prenatal check-up was without abnormalities, and there was no evidence of any drug or Phyto-therapeutic intake. The medical interruption of pregnancy was proposed and refused by the couple.

At 28 weeks of gestation the patient was referred in labor to our structure, the ultrasound on admission showed the same polymalformative complex associated with total amnion, she gave birth to a newborn female, weighing 1700g who died after 6 hours of life due to respiratory distress. The macroscopic inspection revealed: on the cephalic pole: retrognatitis (Figure 1) and posterior encephalocele (Figure 2); on the abdomen: hepatosplenomegaly with ascites; on the limbs: polydactyly (Figure 3) on the 4 distal segments, club feet (Figure 4); cleft palate (Figure 5); examination of the spine and external genital organs was normal. Autopsy examination was not approved by the family. Faced with this poly-malformative syndrome, the diagnosis of Meckel syndrome was suggested.

Discussion

Dysencephalia Splanchnocystica or MKS, all synonyms of the same syndrome due the etymology of the Meckel Gruber Syndrome. In 1822 this syndrome was first described by Johann Friedrich Meckel, a German anatomist, who found two twins who died with identical malformations: occipital encephalocele, polydactyly, and polycystic kidneys [3]. Then, in 1934 George B Gruber described familial cases with the same clinical features, including omphalocele, genital ambiguity and hepatic fibrosis; it was he who proposed the term splacnocystic dysencephaly to these findings [3]. It was Opitz and Howe who proposed the name Meckel-Gruber syndrome with subsequent refinement of the diagnostic criteria [3,4].

Meckel-Gruber syndrome is a lethal, autosomal recessive syndrome; the risk of recurrence is 25% with each pregnancy. It has been frequently described in consanguineous marriages, but also occurs in nonconsanguineous couples. It has a penetrance of 100% and variable expressivity. A wide variety of malformations have been observed in this syndrome, the most consistent being occipital encephalocele, polycystic kidneys and polydactyly [3,4].

The worldwide incidence varies between 1 per 13 250 - 140 000 live births. A high incidence has been reported in the Indian Guajarati population with 1 birth in 3,500 (carrier rate of 1 in 18). There is either a predilection for the population of Finland, where the incidence at birth is 1/9,000. Meckel syndrome is estimated to account for 5% of all neural tube defects in Finland. In Belgian ancestry, the incidence is 1/3,000 persons. The incidence of MKS is also high in consanguineous groups such as the Bedouin tribes of Kuwait (1 in 3,530 live births) [7] and the population of Saudi Arabia (1 in 3,500 live births) [8]. It usually occurs in the context of consanguineous unions; more than 200 cases have been reported in the literature [5,6].

Meckel-Gruber syndrome is caused by mutations in genes encoding proteins that are structural or functional components of primary cilia. The diseases caused by mutations in ciliary genes are collectively called ciliopathies, and the MKS is the most severe of this group of diseases. It can be caused by mutations in any one of at least eight genes; CEP290, B9D1, B9D2, CC2D2A, MKS1, RPGRIP1L, TMEM216, TMEM67. It is known or suspected that the proteins produced by these genes play a role in cellular structures called cilia. Cilia are involved in signaling pathways that transmit information between cells. They are important for the structure and function of many cell types, including brain cells and certain cells in the kidney and liver. Mutations in genes associated with Meckel’s syndrome cause problems with cilia structure and function. Defects in these cellular structures can disrupt chemical signaling pathways important during early development.

MKS is highly phenotypically variable, highly genetically heterogeneous, and antagonistic to other related ciliopathies, such as Joubert syndrome, which greatly complicates diagnosis. Recent advances in genetic engineering have greatly improved diagnosis, genetic counseling, and clinical management of MKS families through the extensive use of multigene panels for molecular testing, unfortunately, these advances in scientific research are not yet accessible.

Autosomal recessive (AR) inheritance of MKS is confirmed by equal occurrence in males and females, concordance in monozygotic twins, examples of affected siblings, and possibly parental consanguinity. If the disease occurred during a previous pregnancy, the risk of recurrence is 25%, Hence the importance of genetic counseling for this couple. In all cases it is necessary to perform a family genealogical tree of the couple for genetic counseling [9]. MKS is fatal in utero or shortly after birth, often due to pulmonary hypoplasia, although there have been exceptional reports of survival [9].

Prenatal diagnosis, in our institution, is fundamentally ultrasound, in this case it occurred at 14 weeks of gestation, which began with abnormal findings in routine standard studies that led to a more detailed study for diagnosis, although it has been described that it could be diagnosed as early as 11-12 weeks, especially in families at high risk through the visualization of anomalies in the central nervous system, kidneys and even in the fingers.

The diagnostic criteria for prenatal Meckel syndrome were based on finding the presence of two of the three classic malformations: occipital meningo-encephalocele, multicystic renal dysplasia and bilateral postaxial polydactyly which are described to be present in 100% of this case [10]; another constant malformation is hepatic fibrosis which could not be established. These findings are thus considered as major criteria for diagnosis [11,12]. Besides hepatic fibrosis, all diagnostic criteria can be assessed by ultrasound diagnosis during the 1st trimester of pregnancy, thus underlining the importance of prenatal diagnosis in this syndrome, given the difficulty of access to genetic diagnosis. Transabdominal ultrasound performed at 10-14 weeks gestation for polycystic kidney disease (after 9 weeks of gestation), occipital encephalocele (after 13 weeks of gestation), and polydactyly (after 11 weeks of gestation), occurring in both high-risk and low-risk pregnancies [9]. Visualization can be affected by oligohydramnios, but is less problematic when performed in the first trimester of pregnancy [13]. Transvaginal scan allows further investigation of abnormalities. The fetal bladder can be seen by ultrasound from week 11 of gestation, and the absence of an apparent fetal bladder frequently indicates renal dysfunction.

Malformations at the central nervous system are variable; defects of the corpus callosum and of the midline in general, hydrocephalus have been described. Posterior fossa dysgenesis (posterior fossa cysts, vermis agenesis, etc.) is also frequent. In all cases postnatal anatomopathological examination is recommended to reach the diagnosis, but this was not possible in this case due to the parent’s decision. There are multiple other malformations described that should be searched in this syndrome, although their frequency is lower, for example, cleft palate (45% of cases) present in this case, cardiac malformations (20%), tongue, splenic malformations, ocular (microphthalmia, retinal dysplasia, congenital cataract, etc.), facial, micrognathia, low-implantation ears [3,14].

Fetal MRI is an alternative if ultrasound is inconclusive or lack of amniotic fluid prevents providing clear images. It can provide better soft-tissue resolution than ultrasound but is rarely performed before 18 weeks’ gestation. the transabdominal or vaginal endoscopy in the first trimester of pregnancy allows the diagnosis by visualization of the surface anatomy of the fetus. Fetoscopy allows direct observation of polydactyly and occipital encephalocele from 11 weeks of gestational age [15]. Prenatal diagnosis is also possible by a combination of these techniques, α-fetoprotein testing of amniotic fluid, and DNA testing of the fetus and parents. For example, elevated maternal α-fetoprotein levels during prenatal screening may be associated with this syndrome [16].

The differential diagnosis should be made with chromosomopathies such as trisomy 13, trisomy 18, in both of which a karyotype would make a diagnosis; with Smith- Lemli-Opitz syndrome, Bardet-Biedl syndrome, Beemer-Langer syndrome, Carpenter-Hunter syndrome, autosomal recessive but genetically heterogeneous Joubert syndrome, which is frequently associated with renal dysplasia and polydactyly, and many other polymalformative syndromes. Diagnostic orientation will be occipital encephalocele, polycystic kidneys, polydactyly and other findings that will be confirmed by autopsy.

Conclusion

The syndrome is a rare disease of autosomal recessive inheritance, of higher frequency in consanguineous couples, although it also occurs in non-consanguineous marriages; the diagnosis, in our environment, is mainly based on ultrasound scan, it has been described that it can be performed from the 11th week in patients with known risk and through genetic diagnosis. Genetic counseling is important since there is a risk of recurrence of 25% in each pregnancy, this will allow the couple to decide on their obstetric future.

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Effects of Strength Training and The Pilates Method on Dynamic Balance, Physical Capacity and Quality of Life in Older People: A Triple-Blind Randomized Clinical Trial - Juniper Publishers

 Yoga and Physiotherapy - Juniper Publishers

Abstract

Objectives: The study aimed to compare the effect of different exercise modalities on dynamic balance, physical capacity, and quality of life. Methods: Fifteen older people aged over 60 years participated in this randomized clinical trial. Group 1 performed resistance training (RG) and Group 2 exercises based on the Pilates method (PG). The dynamic balance behavior was evaluated by Timed Up and Go (TUG) and the 6-minute walk test (6MWT) physical capacity. Quality of life was assessed using the questionnaire SF-36. Results: Regarding balance and physical capacity, we can observe an improvement in the results of TUG and 6MWT, after four weeks of intervention in the PG. No significant differences were found when comparing STG and PG. In terms of quality of life, the criteria of general health and vitality had a statistically significant improvement in the STG and PG. It is concluded that for the older people evaluated in 4 weeks of training, there was no statistically significant difference compared to the groups for the dynamic balance and physical capacity variables. Both strength exercises and Pilates method show significant improvement in criteria assessed in quality of life.

Keywords: Aging; Postural Balance; Physical Capacity; Quality of Life; Physical Training

Abbreviation: RG: Resistance Training, PG: Pilates method, TUG: Timed Up and Go, MWT: Minute Walk Test, UFCSPA: University of Health Sciences of Porto Alegre, SPSS: Statistical Package for Social Science

Background

Physical changes due to the aging process affect muscle strength, balance, and gait, leading to a decline in physical capacity in older people, increasing the chances of falls, morbidity, and mortality among this population [1]. Physical exercise is an intervention used by health professionals for muscle strengthening, physical resistance, and prevention of changes in body balance in the older population. With the practice of exercise, it is possible to obtain an improvement in the risk factors of chronic degenerative diseases, gait speed, muscle weakness, consequently improving the biopsychosocial domains and increasing the quality of life [2,3].

Resistance training has been one of the most common exercise programs applied to the older people, and it has been established that this type of training improves muscle strength, range of motion, levels of functional autonomy, body composition and mental health [4-6].

Among the physical activities recommended for this public, the Pilates method also stands out, which portrays a system of physical exercises created by Joseph Pilates more than a century ago and, even with its multiple ramifications, it is noted that the work with the method is based on the wide variety of movements combined with proper breathing [2,3,5,7,8]. This study is justified by the fact that the literature indicates resistance training and the Pilates method as excellent exercise options for the older people [3,7], however, is not known which of the two has a greater effect on balance, physical capacity, and quality of life in healthy older people, and there is still a lack of standardization in exercise protocols. Therefore, the objective of the present study was to analyze the effect of two different training programs (resistance training versus Pilates method) on the dynamic balance, physical capacity, and quality of life of healthy older people in the community.

Methods

Blinded randomized controlled clinical trial. Approved by the Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre (UFCSPA), under number 2.137.840/2017. Fifteen older people participated in the study, 7 in the Resistance Training group (RG) and 8 in the Mat Pilates group (PG). All volunteers who agreed to participate in the research signed the Informed Consent Form.

Subjects

Older people, residents in the city of Porto Alegre, who were contacted through different sources participated in this study: public invitation, carried out through posters; dissemination on social networks and local dissemination actions with pamphlets. Inclusion criteria were people aged 60 years or older, as established by Brazilian Law No. 8.842 [9], with available time for training. Those who had autonomy and independence, and control of chronic diseases and physical symptoms were considered healthy [10]. Older people who were in a regular physical training program in the last 12 weeks, cognitively impaired, people with a physical disability that prevented them from participating in the groups, in any type of postoperative period or at high risk for performing physical exercises, by cardiopulmonary, vascular, or metabolic disorder, were excluded.

Procedures for Data Collection and Evaluations

The evaluation of the participants was carried out by the same evaluator before and after the training. In the first evaluation, the Mini-Mental exam was performed [11] to assess the individual’s cognitive ability to participate in the study. Dynamic balance was assessed by Timed Up and Go (TUG) test. The test indicates balance and functional mobility, whose performance is related to gait, postural and direction changes during the act of walking, being evaluated through the time spent in carrying out the route [12]. The physical performance was assessed using the Six-Minute Walk Test (6MWT), which measures the maximum distance covered in a period of 6 minutes and is commonly used to assess submaximal cardiorespiratory capacity while performing activities that require commuting. [13]. All individuals were familiarized with the tests previously.

To assess quality of life, participants answered the Medical Outcomes Study 36 - Item Short-Form Health Survey (SF-36) [14] seated in a comfortable and air-conditioned environment.

Intervention Protocol

To ensure the quality of the intervention protocol, as well as the method used in this study, the teams responsible for the training protocols were trained by the responsible researcher to perform the exercises specifically in the RG or PG groups. The study was conducted in secrecy about the training method, focusing on protocol criteria and the safety of participants. The individuals were randomized into two groups, RG and PG, with a training frequency of 3 times a week, over 4 weeks, lasting 60 minutes each. The older people in the RG were first submitted to the estimated test of one repetition maximum (1RM estimated), following the recommendations of the ACSM [15], for each of the exercises of each training cycle. All loads were then adjusted to 70% to 80% of 1RM [15,16]. The protocol was composed of 12 global exercises. The individuals were instructed to perform three sets, from eight to twelve repetitions in each. If the participant reported that the load was light, the load was adjusted again.

In the PG, the protocol had 24 global exercises, all maintaining the principles of the Pilates method. The method is based on 6 principles: control, breathing, fluid movement, precision, concentration, and centering [17]. The exercises were performed with sets of ten repetitions [18]. All exercises were performed on the ground, without the use of equipment. Only accessories such as a Swiss ball, soft ball, stick, dumbbell (1 kg for all individuals) and elastic band were used. [19]. In all sessions, of both groups, the individual was submitted to the same training model, with the same exercises, and if the individual needed any adaptation for the exercise, this was done. In this study, in both training programs, exercises involving strengthening of upper and lower limbs, abdominal and trunk muscles were designed, each modality respecting the characteristics described above. There was a rest period between one exercise and another, not exceeding the time of 1 minute. If the participant reported exhaustion to perform the task, it was finished. No more than 4 individuals were allowed per training schedule, with 2 duly trained instructors to carry out the protocol.

Allocation Sequence Generation

The division between the RG and PG groups occurred after the initial evaluation under analysis of the inclusion and exclusion criteria, following the availability of volunteers’ participation. A table was presented to the older people with the training times, without identifying the modality at each time. According to his availability for training, he stayed in G1 or G2 and only learned the type of training when he participated in it, although the researchers responsible for the training were careful not to mention which method was being used. The health professional who carried out the initial assessment of the elderly was unaware of the schedules for each group, therefore, there was no influence or indication during the choice of the individuals. Both RG and PG offered morning and afternoon schedules, and alternated offering weekly schedules for the beginners. The person responsible for this logistics also kept the assessments confidential for the researchers who conducted the training sessions.

Allocation Masking and Implementation

The evaluators were not aware of the RG and PG training schedules. The researchers responsible for the training were blinded to the evaluation process and to the opposite group. The volunteers were instructed not to comment with the evaluators during the reassessment about the types of exercises they performed. The researcher responsible for analyzing the outcomes was not aware of the allocation of groups, receiving data from the evaluator as Group 1 and Group 2.

Blinding

Due to the masking and implementation of the allocation, the volunteers, the evaluator, the researchers responsible for the training and the researcher responsible for the analysis of the outcomes were blinded.

Statistical Analysis

For data analysis, the Shapiro-Wilk test was performed in order to verify the normality of continuous data. The descriptive analysis of parametric numeric data was expressed as mean and standard deviation, and when non-parametric as median, minimum, and maximum. Descriptions of qualitative variables were expressed in absolute and relative frequency. For inferential analysis, comparisons between RG and PG referring to baseline data were performed using the Student’s t test for independent samples when continuous, and the Chi-square test with Yates correction when categorical. To compare the non-parametric data of the SF-36, the Kruskal Wallis H test and the post hoc Mann Whitney U test were used. Comparisons between GF and GP in the TUG and 6MWT, for the 2 groups in the 2 moments, before and after, were carried out with the Anova Two-Way test with Sheffee’s Post-hoc. All analysis was performed using the Software Statistical Package for Social Science (SPSS, version 21), considering a significance level of 5% (p≤ 0.05).

Results

The present study was composed of 7 individuals in the RG and 8 in the PG. All showed cognitive ability assessed by Mini Mental to participate in the study. The allocation of participants is shown in Figure 1. The characterization of the elderly is presented in (Table 1). There were no differences between the groups in the evaluated variables, demonstrating a homogeneity of the sample, except for the number of female individuals in the GP. The results referring to the applied tests are presented in (Table 2). All the participants were able to complete the dynamic balance and physical capacity tests without interruptions. Regarding the quality of life of the participants, assessed by the SF-36 questionnaire, we can highlight an improvement in the domain of vitality (p=0.008) and general health status (p=0.001) even with statistical significance (Table 3).

Where: SD= standard deviation; n= sample; %= relative sample; RG= resistance group; PG= Pilates group; BMI= body mass index; p¹= Student’s t test to independents sample; p²= Qui-Square test with Yates correction.

Where: n= sample; RG= resistance group; PG= Pilates group; SD= standard deviation; 6MWT= six-minute walk test; p= comparison by Anova Two-Way with Shaffee Post-hoc.

Where: n= sample; RG= resistance group; PG= Pilates group; Min= minimum; Max= Maximum; Med= Median; p= H of Kruskal Wallis with Mann Whitney’s U post hoc.

Discussion

In the present study, we did not observe a statistically significant improvement in relation to the performance in the TUG test, corroborating the findings of Vieira et al [19]. One of their hypotheses would be the intervention duration. In addition, we also believe in the hypothesis that they are healthy elderly people, who already had values considered good for their age group in the initial assessment, and another assessment instrument could provide greater specificity to the results. However, the TUG is the most used instrument to assess balance in the older people [17]. The RG did not show improvements in balance after the intervention period, still demonstrating a decline in its performance. The findings of Low et al [6] e Orr et al [20] claim that resistance training does not generate changes in variables on balance. In order to obtain results on balance in the older people, more dynamic and challenging exercises are recommended, with resistance training indicated as a complement to intervention on this outcome. Because, since balance is dependent on several systems for its maintenance, one should not work on resistance exercises alone [21].

We can observe the improvement in TUG results in relation to the effect on balance in elderly people in PG compared to RG, although not statistically significant. Exercises based on the Pilates method, in general, include dynamic muscle stretching and muscle strengthening using body weight as resistance. [22]. According to Chatzopoulos et al [23] dynamic stretching has a positive effect on balance, unlike static stretching. This being one of the hypotheses that would explain the change in the behavior of equilibrium in RG. Also, studies from Barker et al [24], Bullo et al [25] and Cancela et al [26] concluded that the Pilates method has strong evidence of improvement in static and dynamic balance in older people. Research demonstrate that the Pilates method activates and strengthens the central musculature of the “power house”, required during the execution of the exercises and this can contribute to an improvement in the posture and alignment of the trunk, changing the center of gravity, which directly reflects on the maintenance capacity of body balance [27,28]. Regarding physical capacity, we can observe a greater distance in the 6MWT after four weeks of intervention in the RG, although the comparison between RG and PG reached statistical significance (p=0.06). In exercises based on the Pilates method, planti and dorsiflexors and lower limb strength are worked on simultaneously throughout the exercises [29]. What may have contributed to a better performance in the 6MWT, suggesting that individuals have a more evident improvement in physical capacity with training based on the Pilates Method [18].

According to Santos et al [30], exercises that work on motor coordination are able to provide an increase in gait speed in the older people, also indicating functional independence [31]. Comparing the Pilates method to traditional resistance exercise, it presents a greater degree of difficulty in its execution, since it requires concentration, activation, and coordination of several muscle groups at the same time [22]. In both groups, the SF-36 domains on vitality and general health showed improvements, indicating the positive impact that physical exercise provides in the lives of the elderly. With age-related physical losses, the older people have a reduction in physical activity levels and become more sedentary, reduce their work and social activities, factors that may be associated with a decrease in quality of life [32]. In addition to the health benefits of regular physical activity, seniors find support from other seniors in these groups and end up resuming their social activities. Therefore, physical exercise brings significant changes to the quality of life of older people [32-34].

Existing studies regarding the effect of training on balance in older people have been described in systematic reviews and meta-analyses as having low methodological quality. Which demonstrates the importance of carrying out works encompassing this theme [35,36]. In this study, we evaluated healthy older people. In addition, the average age of the participants demonstrates that they are young older, which could justify the values presented in the TUG in the initial evaluation. According to Alcock et al [37] the postural control of older women suffers worsening with age, with significant annual reductions, with greater oscillation in the most challenging conditions. The number of individuals in this study was a limitation, data collection was terminated early due to the onset of the Covid-19 pandemic. During the study five participants did not stay over the four weeks. It is known that the older population has difficulty in following an activity, mainly due to family commitments, health problems, lack of social and family support [32]. New studies are suggested with larger samples, and with longer duration protocols, in order to identify from what moment, the gains on balance occur. Second Bird [38] to obtain improvements in balance attributed to neuromuscular adaptations, at least 5 weeks of training are required.

Conclusion

The findings of this research showed that in four weeks of training, there was no statistically significant difference compared to the groups for the dynamic balance and physical capacity variables. Both strength exercises and the Pilates method show significant improvement in criteria evaluated in quality of life, which is extremely relevant, showing that, regardless of the time of performance, these modalities bring benefits to healthy older people.

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The Role of The Coach in Elite Equestrian Sport - Juniper Publishers

Physical Fitness, Medicine & Treatment in Sports - Juniper Publishers

Abstract

British Equestrian (BE) aims to develop a holistic coach education and certification program, moving away from traditional autocratic instruction in line with the United Kingdom (UK) Coaching Framework. This framework is based on generic coaching science research where the coach is cited as a pivotal aspect in developing sporting success. Theoretic knowledge suggests that the role of the sports coach is to develop the physical, tactical, technical and psychological attributes of the athlete and is responsible for the planning, organization and delivery of the training plan and competition schedule. However, there is no empirical evidence to suggest that is the role required in equestrian sport, as the rider often takes responsibility for many of these tasks. This research aimed to address the void in current knowledge by gaining an understanding of coaching in equestrian sport at the elite level, to improve coaching education systems through awareness of the role of the coach. A qualitative method using semi-structured interviews was used. A sample of elite coaches (N=3) and elite riders (N=3) were interviewed. Analysis of the transcripts revealed a total of 534 meaning units that were further grouped into sub-themes and general themes from the coaches’ perspective and the riders’ perspective. This led to the development of a final thematic structure revealing major dimensions that characterized coaching in elite equestrian sport. It was found that the riders at the elite level, coach themselves most of the time therefore can be considered as ‘self-coached’ athletes. However, they do use elite coaches in a mentoring and consultancy role, where they seek guidance from the coach on specific problems, to sound ideas off or to seek reassurance that what they are doing is correct. Findings from this research suggest that the rider-coach relationship at the elite level is a professional one, based on trust and respect, but not a close relationship, as seen in other sports. The results show the imperative need for the BE to educate coaches in coaching the self-coached rider at the elite level, particularly in terms of mentoring skills. As well as incorporating rider education aimed at developing the independent, self-coached riders.

Keywords: Coach; Elite; Equestrian sport

Introduction

Equestrian sporting origins are deeply rooted in military tradition, both in the development of the sport and the training of the horse and rider. Equestrian sports are unique as they test the rider’s mastery over the horse in terms of athleticism, control, and accuracy. British Equestrian (BE), the umbrella governing body of equestrian sport, represents 10 sports including the Olympic disciplines of evening, Show Jumping and Dressage. It works to promote the interests of 3 million riders and carriage drivers in the United Kingdom. The Federation is responsible for distributing government funds from UK Sport with an aim to win more medals on the world stage and to get more people participating in equestrian sports. BE places the coach as an integral part in achieving these aims. Substantial sports coaching literature has identified the importance of the role of the coach in sporting success as they are pivotal in the development of physical, tactical, technical, and psychological attributes of the athlete. However, equally important is the role the coach plays in the overall enjoyment, satisfaction and ultimately retention of people participating in the sporting activity. The basic role of any sport coach is to develop and improve the sporting performance of the team or individual. However, as participation in sport is usually voluntary, the experiences encountered can make or break a participant’s continuation in the sport. If the experience is not satisfactory, they are likely to leave the sport. The coach is therefore the key component to whether the activity is positive, and the quality of this experience depends on the coach’s value, principles, and beliefs.

It is acknowledged that the role of the coach is diverse and often not fully understood. Indeed, modern day coaching practitioners are not only responsible for directing practice and training sessions but also for the overall social and psychological well-being of their athlete both inside and outside of the sporting arena. Therefore, as [1] points out, to fully understand the role of the coach a critical analysis is needed of the nuances, actions, behaviour, and complexities used by sport specific coaching practitioners. This suggests that there needs to be recognition of the layers of skill and competencies required, how these interact with each other and how they impact on performance. Research has identified that successful coaches across a range of sports have several qualities in common: the ability to select the most important leadership behaviour; a personal desire to foster individuals’ growth; organizational skills in planning and preparation; a strong sense of goals, philosophy, and personality. This indicates that coaching cannot be viewed as purely a series of actions but a complex model of overlapping aspects. Research supports this by suggesting that coaches require additional skills above the technical knowledge of their sport and that these include pedagogical skills of a teacher, counselling skills of a psychologist, fitness training skills of a physiologist and the administrative and leadership skills of a business executive [2] also includes the role of a mentor and pillar of support to the athlete [3] clarifies the practice of coaching as a complex, dynamic, social domain and context dependent enterprise with often contradictory goals and values. Understanding these complexities is key to evaluating the purpose of the coach, needed in coach education to develop and improve coaching skills. The training of coaches is seen as essential to sustaining and improving the quality of coaching and on-going professionalism. Yet, [4] points out that currently coach development programs use a competency-based approach. This is, in fact, true of the BE who have developed a certification program in line with UK Sport’s United Kingdom Coaching Certification (UKCC). This is a move away from the traditional autocratic style ‘instructor’ to an ‘athlete-centered’, holistic approach to coaching. The traditional system, whilst acknowledged worldwide as a comprehensive program developing basic riding skills was an authoritarian approach to teaching riding. The syllabus was based on the ‘classical’ tradition of training horses based in the military past and lacked scientific validity. The current focus on the holistic approach and the development of an athlete, is supported in other areas of coaching, physical education and indeed education. A strong athlete-centered coaching approach emphasizing the development of self-confidence and belief in one’s ability is essential in making the correct decisions in a competitive situation. Producing ‘independent learners’ and ‘independent ‘decision markers’; may be key to the equestrian model as the rider is often considered as the ‘leader’ and non-verbal decision maker of the team.

Decisions made during riding must be made quickly and have dynamic consequences. The rider must calculate so many variables and translate them to effective communication with the horse. The rider needs to make the correct decisions at the right time and failure to make correct decisions can be catastrophic. This requires quick cognitive function, complex tasks, and choice reaction times. Indeed, it is this quick proprioceptive processing and effective decision making that are key to effective horse riding. This can only be achieved if the rider is empowered to be independent leaders that are confident decision makers. Olympic rider and coach, Phillip Dutton agrees: “You need to be strong and independent enough so you can ride without an instructor watching you all the time, holding your hand, and doing everything for you. Eventing is a sport where you are out there on your own especially cross-country phase. Your instructor may help you gain skills and improve your riding, but you must develop your mind and confidence so that when you are on course you can do it on your own [5].

To attain this holistic approach to coaching a substantial amount of literature has revealed the importance of the coach-athlete relationship and that the strength of this relationship should be based on closeness, co-orientation, and complementarity (3Cs). However, literature, mainly popular and non-academic, suggests that it is the rider that is responsible for the training of the horse in terms of fitness, skill, and technique as well as the management and wellbeing of the horse. They also assume the planning of competition schedules as well as most of the tactical and technical support, therefore it can be assumed that in part, they coach themselves. There is little empirical research to identify what the role of the equestrian coach is in this triad relationship. Therefore, the aim of the study was to gain an understanding of the role of the coach in elite equestrian sport to improve coaching education systems through awareness of the role of the coach. The first objective was to examine the relationship between coach and rider at elite level in equestrian sport providing empirical evidence to suggest that the rider is, in part, ‘self-coached’. The second objective was to identify what elite equestrian coaches believed their role is in the development of safe and effective riders.

Method

Sampling

The research question was developed with regards to elite equestrian coaches and riders as the study of their inferences could be drawn and applied to coach education. As there is no cohesive definition of an expert coach or valid ways to identify expertise, almost all research relies on years of experience or level of performance. As this study formulates primary research in the field of equestrian coaching and due to the large number of variables associated with the sport a top-down approach researching the elite level was chosen. Therefore, the principles of purposeful sampling were implemented using the following criteria: Three elite equestrian coaches were selected who were currently coaching on the BEF World Class Programme and working with GB senior team riders competing at the international level. A list of subjects that met the criteria, were drawn up and were approached based on location to researcher. One female coach and two male coaches were interviewed, one specialised in dressage, one show jumping and one in eventing, although all had had experience of coaching event riders. All were known in a professional manner to the researcher. Three elite riders were selected using the following criteria: member of the BEF World Class Programme and had represented Team GB at senior level during the past year. Three riders were selected from a possible 32 across the disciplines of eventing, dressage and show jumping. Two riders competed in eventing, one in the discipline of Show Jumping and were selected on location to researcher and were also known in a professional manner to the researcher.

Instrument

A semi-structured interview schedule that prompted responses to open ended questions about the roles and relationships of coach and rider was chosen as the method for this study. A semi-structured interview guide (Table 1 & 2) was developed to allow the interviewer to explore the relationships and roles within the coaching process. Participants were informed that there were no right or wrong answers, they were asked to take their time to respond to questions or to tell the interviewer if they did not understand the question. In addition to the semistructured questions specific probes were identified for each question and encouraged participants to elaborate on their responses.

Data collection

Coaches and riders were approached via phone call or email by the author and invited to participate in the study. After explanation of the aims and background of the study, interviews were arranged at a time and place elected by the interviewee. The interviews ranged from 25-55mins and were audiotaped with participants’ consent. The interviews were later transcribed verbatim into A4 single-spaced text.

Pilot study

A pilot study was carried out to assess the effectiveness of the questions selected. One elite coach was selected to be interviewed. Responses were forthcoming and met expectations. However, to validate the results further it was decided to also interview riders to gain their perspective of the role of the coach and the relationship they have with their coach. A further pilot interview was carried out with an elite rider to again assess the effectiveness of the questions selected.

Data analysis

Thematic Analysis was used as a systematic method for exploring the contents of the obtained data.

Ethics & Limitations

Ethical approval was granted by Hartpury University. The interviewees remained anonymous and confidential throughout the study, however, due to the high-profile nature of the sample it may be possible for people in the equine industry to identify subjects from their responses, however all efforts were made to retain anonymity and participants were given a letter and number as a means of identification through the study. Questioning topics did not cover intrusive or overtly personal subject areas. All participants were over the age of 18 and choose to take part under their own free will and were able to withdraw from the study at any time. Informed consent from the coach and riders were obtained prior to the interviews being recorded. The Data, both audio recordings and transcripts were stored in accordance with the Data Protection Act 1998.

The limitations of using a semi structured interview technique are that not all people are equally cooperative, articulate, and perceptive. The interviewer requires skill, not only to select and ask the appropriate questions clearly, but to gain the interviewees trust and confidence for them to elicit a full and honest response.

As a result, it is not a natural tool for gathering data as it requires interaction between two parties. However, due to knowledge level and experience of the researcher regarding equine performance these limitations are reduced.

Results

Analysis of the transcripts revealed a total of 534 meaning units that were further grouped into sub-themes and general themes from the coaches’ perspective (Table 3) and the riders’ perspective (Table 4). This led to the development of a final thematic structure revealing major dimensions that characterized coaching in elite equestrian sport (Table 5 & 6).

Discussion

Self-coach athletes

Analysis of data suggests that riders at the elite level in equestrian sport are in part ‘self-coached’. The results of the study show that riders attend a training session with a coach less than once a week and some as little as once a month. The remaining time the individual rider is responsible for all training decisions including horse selection; competition planning; implementation of periodization plans; management of support staff. Training decisions are made by the riders based on experience and knowledge of the individual horse. Therefore, in depth knowledge is needed by the rider in all areas. The development of the equestrian UKCC qualifications has incorporated the importance of planning for the coach but fails to acknowledge that it is the rider that plans the program. It was acknowledged by both the riders and coaches that consideration for the horse’s wellbeing and ensuring they were willing to do the task being asked was a key factor in their planning. This is because the equine has no concept of the goals involved. Coach C1 clarified this by stating “It is better to have the horse 90% prepared or 90% fit and 10% willing than have 100% prepared but you have no willingness”. This is in direct contrast to literature in other sports where being 100% prepared is necessary for sporting success. Therefore, any equestrian plan needs to suit the temperament of the horse. The results highlighted that knowledge and understanding of the psychology of the individual horse was significant and that as the rider has a close relationship with their horse, they are in the best position to make these training decisions. However, the equestrian UKCC syllabus does not incorporate any aspect of equine psychology or horse management, although these topics are still present in the other equine coach certification systems.

All riders in the study identified that how the horse ‘feels’ is the deciding factor in increasing intensity of training or increase in competition level, this suggests that there is an element of reflective analysis occurring and highlights the importance for developing and understanding this concept of ‘feel’. Yet there was no evidence to suggest riders use an objective analysis approach, this may be due to lack of knowledge by the rider and lack of research reaching the industry e.g., use of heart rate monitors, biomechanical analysis etc. There is also a lack of consistency both in literature and amongst the participants as to what actually constitutes ‘feel’. More research is needed to define this concept in equestrian sport and how it is developed to enable it to be taught or coached more effectively.

During their self-coaching training, all riders stated that they used outside observers either grooms, family members or friends to gain feedback. However, the quality of these observers is unknown. This is an area that requires focus and providing quality education to this support team needs consideration. A greater understanding of the self-coached riders is needed to fully feed into education programs for riders at all levels as well as an understanding of how the coach can support the self-coached rider optimally.

Coach-rider relationship

Current research in the field of coaching science recognizes that sport is not immune from the social world and that to examine the dynamic coaching process contextual social factors must be considered. Indeed, any activity that involves human beings is complex, interpersonal and that relationships are contested at levels of meaning, value, and practices. The relationship between the coach and the athlete is not an add-on or by-product of the coaching process but could be considered the foundation of coaching. Therefore, the coach-athlete relationship can be defined by mutual and casual interdependence between coaches and athlete feelings, thoughts, and behaviour, suggesting shared goals and values [6] proposed that successful coach athlete relationships are based on four concepts: closeness (trust and respect); commitment (shared goals and connection); complementarity (interaction that is co-operative and effective); co-orientation (acceptance of individual roles). However, previously there is no evidence to suggest these are used in equestrian sport.

The interpersonal relationship between athlete and coach plays a significant role in the sporting lives of the athlete and is likely to determine satisfaction in the sport, self-esteem and confidence and ultimately successful sporting performance.

However, knowledge and understanding of these relationships remains limited at both the theoretical and empirical level. This study elucidated that the relationship between the coach and rider was a professional one that could be described as reciprocal, yet asymmetrical characterised by a unique relationship between individuals and depended upon experience and age difference. This study revealed riders sought a coach that was approachable, that they felt comfortable discussing ideas with and that they trusted and respected. This view is supported in other sports; however, the riders did not describe the relationship as ‘close’. Yet closeness is considered by Jowett’s 3Cs as a key component of the in successful coach-athlete relationships. This may be in part due to the limited contact riders have with their coaches. Contact was mixed amongst the subjects; one respondent only saw their coach during periodic World Class training which may explain why their relation was not considered ‘close’. Further research is needed to fully quantify the ‘norm’ for contact time with coaches across equestrian sport at varied rider levels.

Respect and trust

The emerging themes that were expressed by the rider participants show some commonality in their lower order themes, that they desire a coach that they trust and respect. All participants claimed that this respect was generated from the coaches’ own riding experience and level in which they had competed. It was felt that this was needed to not only have credibility but also to have the knowledge of riding a variety of horses at the elite level and to have the appropriate repertoire of training solutions. The ability to have the concept of ‘feel’ of the individual horse was also deemed important. One participant commented that: “It is also really useful for them to get on the horse so they can feel what I feel” R1. This suggests that equestrian coaching is largely experienced-linked and situation-specific base, like that required in the sport of sailing. Such an important statement is worthy of further investigation as other equestrian coaching qualifications include riding tests as part of their qualification curriculum, whereas the UKCC does not. Interestingly the elite coaches acknowledge the advantage of riding experience for a successful coach but felt that this was not necessary. This is supported in other sports where the best coaches are not always elite athletes but have had experience of competing just below the elite level, this may well not be applicable in equestrian coaching at elite level.

Mentor relationship

Riders in this study referred to their chosen coach when they needed advice or mentoring. One way by which the riders identified this mentoring relationship was that they used a coach as a sounding board for ideas. This was, in part, used to gain confidence and reassurance in the knowledge that what they were doing was correct. They also used the coach as a mentor when they had a particular problem or needed a fresh approach to a particular horse or situation. Whilst BE acknowledges the importance of mentoring skills within coaching, it fails to clarify what these skills actually are, yet it can be accepted that it is a form of supported learning through social interaction. Evidence from these interviews suggests this is achieved through a shift between support and challenge.

Facilitator in the development of safe and effective riders

[7] when analysing relationships within the caring professions, identified good mentors as challenge givers, the collective viewpoint expressed by the participants indeed concurs with this within this study. Emphasis was placed on the element of challenging the rider. This may be since in the remaining time the riders are self-coaching and may not be motivated or confident to push themselves outside their comfort zone. C1 expressed this view “that they go over what they are comfortable doing and that they are good at” C1 29-30. Within this study the findings concluded that the elite equestrian coaches facilitated this challenging environment by setting up exercises that allow riders to experiment, for example, different approaches to jumping a combination. This suggests a move away from skill practice to development of perception and decision-making processes. This allowed the riders to make mistakes and learn from these mistakes. The coaches in this study stated that they achieve a learning experience by discuss those mistakes, getting them to think how they would ride the exercise differently and creating awareness of feel in relation to position. This cognitive action through a guided discovery approach achieves an empowerment process.

Similarly, to other sports, feel or body awareness in equestrian sports is achieved through drills and repetition. Riders felt this fed into positively developing their own confidence, improving their cognitive awareness and automatic decision-making processes. More research is needed in this area to understand which exercise or drills are the most effective in developing this aspect within equestrian coaching.

Recommendations

The results from this study provide substantial evidence for the need to incorporate the topic of coaching the self-coached rider into equestrian coaching education systems at elite level. Coaches should be aware of the demands and limitations of coaching the self-coached rider and appreciate the importance of their role in the successful outcome of the horse/rider dyad in equestrian competition. BE should highlight and develop the role of the coach as a mentor to self-coached riders at the elite level. Amalgamation of both phases of this study combined with the themes that emerged from the interviews provides the following recommendations:

a) Role of the coach in Equestrian UKCC education should be clearly identified

b) Further development of mentoring skills of coaches

c) Identification of techniques that facilitate the development of ‘self-aware’ and ‘self-reliant’ effective decisionmaking riders

d) Development of rider skills to self-coach in terms of planning and implementing training, developing all areas of psychology, equine psychology, injury prevention etc. and analysis

e) Increasing the use of tools to enable the self-coached rider to analyse performance in both training and competition environment

Limitations of Study and Future Research

It is important to highlight the limitations inherent in the study which must be considered against the results that emerged. The sample size used in the study was small (coaches N=3, riders N=3) however, the selection criteria was carefully applied and even though the sample size was small it could justifiably be seen as offering expert opinions therefore, the findings are directly applicable to elite coaches and riders. Future research is required with differing levels of riders and equestrian coaches working to provide validity across all equestrian participants. More indepth research is indicated investigating individual equestrian sports in greater detail to examine any differences that may arise in each discipline. As expected, with any attempt to summarize or condense findings from the semi-structured interviews, not all participants were as forthcoming as each other and did not respond in the same way or to the same extent to the identified themes. The practical coaching processes were not quantified, therefore this study relied on the participants perception of coaching and the role of the coach, whilst this is a legitimate form of qualitative research the study could have included coaching observations. using video analysis to evaluate the coaching process and identify evidence of the coaching roles displayed in practice [8-54].

Conclusion

In equestrian sports there is a unique triad relationship between the horse, rider, and coach. The rider assumes many responsibilities that are undertaken by the coach in other sports, such as planning training schedules, nutrition, competition schedule, tactics etc. As a result, we can consider the elite rider often as a self-coached athlete. The findings of this study were that elite equestrian athletes therefore used a coach primarily as a mentor and that this mentoring role includes problem solving and reassurance that the training and management techniques being used are correct. Within the coached training sessions, the coach assumed the role of a facilitator, challenging the riders in a holistic manner with a specific aim to develop independent decision makers. In this study riders felt that their relationship with their coach was one of a professional nature and that they selected a coach that they trusted and respected. This was based on the level and experience of the coach as a competitive rider. This has implication on the current BE coach certification system that does not assess riding ability. Considering these findings, the BE needs to address coach education in terms of holistic practice, specifically regarding coaching the self-coached rider. Further research is indicated, establishing links between riders’ natural ‘feel’ and the development of correct decision making in equestrian sport. This will enable a better understanding of how the BE can develop coaches who will successfully facilitate and mentor essential and equestrian specific skills at all levels and across all disciplines.

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Effects of Strength Training and The Pilates Method on Dynamic Balance, Physical Capacity and Quality of Life in Older People: A Triple-Blind Randomized Clinical Trial - Juniper Publishers

Yoga and Physiotherapy - Juniper Publishers

Abstract

Objectives: The study aimed to compare the effect of different exercise modalities on dynamic balance, physical capacity, and quality of life. Methods: Fifteen older people aged over 60 years participated in this randomized clinical trial. Group 1 performed resistance training (RG) and Group 2 exercises based on the Pilates method (PG). The dynamic balance behavior was evaluated by Timed Up and Go (TUG) and the 6-minute walk test (6MWT) physical capacity. Quality of life was assessed using the questionnaire SF-36. Results: Regarding balance and physical capacity, we can observe an improvement in the results of TUG and 6MWT, after four weeks of intervention in the PG. No significant differences were found when comparing STG and PG. In terms of quality of life, the criteria of general health and vitality had a statistically significant improvement in the STG and PG. It is concluded that for the older people evaluated in 4 weeks of training, there was no statistically significant difference compared to the groups for the dynamic balance and physical capacity variables. Both strength exercises and Pilates method show significant improvement in criteria assessed in quality of life.

Keywords: Aging; Postural Balance; Physical Capacity; Quality of Life; Physical Training

Abbreviation: RG: Resistance Training, PG: Pilates method, TUG: Timed Up and Go, MWT: Minute Walk Test, UFCSPA: University of Health Sciences of Porto Alegre, SPSS: Statistical Package for Social Science

Background

Physical changes due to the aging process affect muscle strength, balance, and gait, leading to a decline in physical capacity in older people, increasing the chances of falls, morbidity, and mortality among this population [1]. Physical exercise is an intervention used by health professionals for muscle strengthening, physical resistance, and prevention of changes in body balance in the older population. With the practice of exercise, it is possible to obtain an improvement in the risk factors of chronic degenerative diseases, gait speed, muscle weakness, consequently improving the biopsychosocial domains and increasing the quality of life [2,3].

Resistance training has been one of the most common exercise programs applied to the older people, and it has been established that this type of training improves muscle strength, range of motion, levels of functional autonomy, body composition and mental health [4-6].

Among the physical activities recommended for this public, the Pilates method also stands out, which portrays a system of physical exercises created by Joseph Pilates more than a century ago and, even with its multiple ramifications, it is noted that the work with the method is based on the wide variety of movements combined with proper breathing [2,3,5,7,8]. This study is justified by the fact that the literature indicates resistance training and the Pilates method as excellent exercise options for the older people [3,7], however, is not known which of the two has a greater effect on balance, physical capacity, and quality of life in healthy older people, and there is still a lack of standardization in exercise protocols. Therefore, the objective of the present study was to analyze the effect of two different training programs (resistance training versus Pilates method) on the dynamic balance, physical capacity, and quality of life of healthy older people in the community.

Methods

Blinded randomized controlled clinical trial. Approved by the Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre (UFCSPA), under number 2.137.840/2017. Fifteen older people participated in the study, 7 in the Resistance Training group (RG) and 8 in the Mat Pilates group (PG). All volunteers who agreed to participate in the research signed the Informed Consent Form.

Subjects

Older people, residents in the city of Porto Alegre, who were contacted through different sources participated in this study: public invitation, carried out through posters; dissemination on social networks and local dissemination actions with pamphlets. Inclusion criteria were people aged 60 years or older, as established by Brazilian Law No. 8.842 [9], with available time for training. Those who had autonomy and independence, and control of chronic diseases and physical symptoms were considered healthy [10]. Older people who were in a regular physical training program in the last 12 weeks, cognitively impaired, people with a physical disability that prevented them from participating in the groups, in any type of postoperative period or at high risk for performing physical exercises, by cardiopulmonary, vascular, or metabolic disorder, were excluded.

Procedures for Data Collection and Evaluations

The evaluation of the participants was carried out by the same evaluator before and after the training. In the first evaluation, the Mini-Mental exam was performed [11] to assess the individual’s cognitive ability to participate in the study. Dynamic balance was assessed by Timed Up and Go (TUG) test. The test indicates balance and functional mobility, whose performance is related to gait, postural and direction changes during the act of walking, being evaluated through the time spent in carrying out the route [12]. The physical performance was assessed using the Six-Minute Walk Test (6MWT), which measures the maximum distance covered in a period of 6 minutes and is commonly used to assess submaximal cardiorespiratory capacity while performing activities that require commuting. [13]. All individuals were familiarized with the tests previously.

To assess quality of life, participants answered the Medical Outcomes Study 36 - Item Short-Form Health Survey (SF-36) [14] seated in a comfortable and air-conditioned environment.

Intervention Protocol

To ensure the quality of the intervention protocol, as well as the method used in this study, the teams responsible for the training protocols were trained by the responsible researcher to perform the exercises specifically in the RG or PG groups. The study was conducted in secrecy about the training method, focusing on protocol criteria and the safety of participants. The individuals were randomized into two groups, RG and PG, with a training frequency of 3 times a week, over 4 weeks, lasting 60 minutes each. The older people in the RG were first submitted to the estimated test of one repetition maximum (1RM estimated), following the recommendations of the ACSM [15], for each of the exercises of each training cycle. All loads were then adjusted to 70% to 80% of 1RM [15,16]. The protocol was composed of 12 global exercises. The individuals were instructed to perform three sets, from eight to twelve repetitions in each. If the participant reported that the load was light, the load was adjusted again.

In the PG, the protocol had 24 global exercises, all maintaining the principles of the Pilates method. The method is based on 6 principles: control, breathing, fluid movement, precision, concentration, and centering [17]. The exercises were performed with sets of ten repetitions [18]. All exercises were performed on the ground, without the use of equipment. Only accessories such as a Swiss ball, soft ball, stick, dumbbell (1 kg for all individuals) and elastic band were used. [19]. In all sessions, of both groups, the individual was submitted to the same training model, with the same exercises, and if the individual needed any adaptation for the exercise, this was done. In this study, in both training programs, exercises involving strengthening of upper and lower limbs, abdominal and trunk muscles were designed, each modality respecting the characteristics described above. There was a rest period between one exercise and another, not exceeding the time of 1 minute. If the participant reported exhaustion to perform the task, it was finished. No more than 4 individuals were allowed per training schedule, with 2 duly trained instructors to carry out the protocol.

Allocation Sequence Generation

The division between the RG and PG groups occurred after the initial evaluation under analysis of the inclusion and exclusion criteria, following the availability of volunteers’ participation. A table was presented to the older people with the training times, without identifying the modality at each time. According to his availability for training, he stayed in G1 or G2 and only learned the type of training when he participated in it, although the researchers responsible for the training were careful not to mention which method was being used. The health professional who carried out the initial assessment of the elderly was unaware of the schedules for each group, therefore, there was no influence or indication during the choice of the individuals. Both RG and PG offered morning and afternoon schedules, and alternated offering weekly schedules for the beginners. The person responsible for this logistics also kept the assessments confidential for the researchers who conducted the training sessions.

Allocation Masking and Implementation

The evaluators were not aware of the RG and PG training schedules. The researchers responsible for the training were blinded to the evaluation process and to the opposite group. The volunteers were instructed not to comment with the evaluators during the reassessment about the types of exercises they performed. The researcher responsible for analyzing the outcomes was not aware of the allocation of groups, receiving data from the evaluator as Group 1 and Group 2.

Blinding

Due to the masking and implementation of the allocation, the volunteers, the evaluator, the researchers responsible for the training and the researcher responsible for the analysis of the outcomes were blinded.

Statistical Analysis

For data analysis, the Shapiro-Wilk test was performed in order to verify the normality of continuous data. The descriptive analysis of parametric numeric data was expressed as mean and standard deviation, and when non-parametric as median, minimum, and maximum. Descriptions of qualitative variables were expressed in absolute and relative frequency. For inferential analysis, comparisons between RG and PG referring to baseline data were performed using the Student’s t test for independent samples when continuous, and the Chi-square test with Yates correction when categorical. To compare the non-parametric data of the SF-36, the Kruskal Wallis H test and the post hoc Mann Whitney U test were used. Comparisons between GF and GP in the TUG and 6MWT, for the 2 groups in the 2 moments, before and after, were carried out with the Anova Two-Way test with Sheffee’s Post-hoc. All analysis was performed using the Software Statistical Package for Social Science (SPSS, version 21), considering a significance level of 5% (p≤ 0.05).

Results

The present study was composed of 7 individuals in the RG and 8 in the PG. All showed cognitive ability assessed by Mini Mental to participate in the study. The allocation of participants is shown in Figure 1. The characterization of the elderly is presented in (Table 1). There were no differences between the groups in the evaluated variables, demonstrating a homogeneity of the sample, except for the number of female individuals in the GP. The results referring to the applied tests are presented in (Table 2). All the participants were able to complete the dynamic balance and physical capacity tests without interruptions. Regarding the quality of life of the participants, assessed by the SF-36 questionnaire, we can highlight an improvement in the domain of vitality (p=0.008) and general health status (p=0.001) even with statistical significance (Table 3).

Where: SD= standard deviation; n= sample; %= relative sample; RG= resistance group; PG= Pilates group; BMI= body mass index; p¹= Student’s t test to independents sample; p²= Qui-Square test with Yates correction.

Where: n= sample; RG= resistance group; PG= Pilates group; SD= standard deviation; 6MWT= six-minute walk test; p= comparison by Anova Two-Way with Shaffee Post-hoc.

Where: n= sample; RG= resistance group; PG= Pilates group; Min= minimum; Max= Maximum; Med= Median; p= H of Kruskal Wallis with Mann Whitney’s U post hoc.

Discussion

In the present study, we did not observe a statistically significant improvement in relation to the performance in the TUG test, corroborating the findings of Vieira et al [19]. One of their hypotheses would be the intervention duration. In addition, we also believe in the hypothesis that they are healthy elderly people, who already had values considered good for their age group in the initial assessment, and another assessment instrument could provide greater specificity to the results. However, the TUG is the most used instrument to assess balance in the older people [17]. The RG did not show improvements in balance after the intervention period, still demonstrating a decline in its performance. The findings of Low et al [6] e Orr et al [20] claim that resistance training does not generate changes in variables on balance. In order to obtain results on balance in the older people, more dynamic and challenging exercises are recommended, with resistance training indicated as a complement to intervention on this outcome. Because, since balance is dependent on several systems for its maintenance, one should not work on resistance exercises alone [21].

We can observe the improvement in TUG results in relation to the effect on balance in elderly people in PG compared to RG, although not statistically significant. Exercises based on the Pilates method, in general, include dynamic muscle stretching and muscle strengthening using body weight as resistance. [22]. According to Chatzopoulos et al [23] dynamic stretching has a positive effect on balance, unlike static stretching. This being one of the hypotheses that would explain the change in the behavior of equilibrium in RG. Also, studies from Barker et al [24], Bullo et al [25] and Cancela et al [26] concluded that the Pilates method has strong evidence of improvement in static and dynamic balance in older people. Research demonstrate that the Pilates method activates and strengthens the central musculature of the “power house”, required during the execution of the exercises and this can contribute to an improvement in the posture and alignment of the trunk, changing the center of gravity, which directly reflects on the maintenance capacity of body balance [27,28]. Regarding physical capacity, we can observe a greater distance in the 6MWT after four weeks of intervention in the RG, although the comparison between RG and PG reached statistical significance (p=0.06). In exercises based on the Pilates method, planti and dorsiflexors and lower limb strength are worked on simultaneously throughout the exercises [29]. What may have contributed to a better performance in the 6MWT, suggesting that individuals have a more evident improvement in physical capacity with training based on the Pilates Method [18].

According to Santos et al [30], exercises that work on motor coordination are able to provide an increase in gait speed in the older people, also indicating functional independence [31]. Comparing the Pilates method to traditional resistance exercise, it presents a greater degree of difficulty in its execution, since it requires concentration, activation, and coordination of several muscle groups at the same time [22]. In both groups, the SF-36 domains on vitality and general health showed improvements, indicating the positive impact that physical exercise provides in the lives of the elderly. With age-related physical losses, the older people have a reduction in physical activity levels and become more sedentary, reduce their work and social activities, factors that may be associated with a decrease in quality of life [32]. In addition to the health benefits of regular physical activity, seniors find support from other seniors in these groups and end up resuming their social activities. Therefore, physical exercise brings significant changes to the quality of life of older people [32-34].

Existing studies regarding the effect of training on balance in older people have been described in systematic reviews and meta-analyses as having low methodological quality. Which demonstrates the importance of carrying out works encompassing this theme [35,36]. In this study, we evaluated healthy older people. In addition, the average age of the participants demonstrates that they are young older, which could justify the values presented in the TUG in the initial evaluation. According to Alcock et al [37] the postural control of older women suffers worsening with age, with significant annual reductions, with greater oscillation in the most challenging conditions. The number of individuals in this study was a limitation, data collection was terminated early due to the onset of the Covid-19 pandemic. During the study five participants did not stay over the four weeks. It is known that the older population has difficulty in following an activity, mainly due to family commitments, health problems, lack of social and family support [32]. New studies are suggested with larger samples, and with longer duration protocols, in order to identify from what moment, the gains on balance occur. Second Bird [38] to obtain improvements in balance attributed to neuromuscular adaptations, at least 5 weeks of training are required.

Conclusion

The findings of this research showed that in four weeks of training, there was no statistically significant difference compared to the groups for the dynamic balance and physical capacity variables. Both strength exercises and the Pilates method show significant improvement in criteria evaluated in quality of life, which is extremely relevant, showing that, regardless of the time of performance, these modalities bring benefits to healthy older people./p> 

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