Rationale

There is a growing body of evidence indicating that incorporating complementary and alternative approaches into one’s lifestyle, which involve increasing physical activity and decreasing sedentary behaviors, can have positive effects on one’s health. Yoga, an ancient Indian practice, has become increasingly popular in western countries (Ding et al 2014). It primarily involves gentle static stretching postures, conscious breathing, and meditation to promote flexibility and relaxation. Hatha yoga, which is a branch of yoga and consists of physical postures, conscious breathing, and meditation, is the most commonly practiced form (Feuerstein,2004). Yoga is generally considered safe and easy to learn, and does not require specialized equipment or training facilities, making it an appealing alternative form of exercise that may lead to high exercise adherence (Bryan et al 2012). The effect of yoga on preventing muscular weakness due to sarcopenia and improving muscle strength, mass and functional performance is examined in few studies but needs to be examined further in obese patients with dynapenia/sarcopenia. This will be the first trial which will use progressive yoga technique in management of dynapenia/Sarcopenia in obese subjects. Yogic exercise which causes an increase in muscle strength, function and mass requires a considerable amount of upper and lower body strength, therefore progressive yogic exercises will be provided to the subjects in the study. Yoga may not only improve muscle strength and function but it may also help in weight loss and increasing flexibility in study subjects.

Objectives

Primary objectives

1. To compare the effect of progressive yogic exercises versus moderate intensity physical activity with standard diet on skeletal muscle mass, strength and function in obese subjects with Dynapenia/Sarcopenia. 
2. To compare the effect of yogic exercises versus moderate intensity physical activity with standard diet on skeletal muscle mass, strength and function in obese subjects with Dynapenia/Sarcopenia.

Secondary objectives

1. To compare the effect of aforementioned interventions on flexibility, anthropometric parameters, body composition and quality of life in obese individuals with Dynapenia or sarcopenia.
2. To compare the effect of aforementioned interventions on metabolic and biochemical parameters in obese individuals with Dynapenia or Sarcopenia. 
3. To assess the acceptability of the aforementioned interventions by assessing the dropout rate, adherence to the intervention as depicted by their daily notes in the diary with subjective description about the intervention.

Hypothesis

Progressive yogic exercises will not only improve muscle strength and function but also help in weight loss and increasing flexibility in study subjects in comparison to standard diet and exercise.

Novelty

Yoga, an ancient Indian practice for physical and mental discipline, has been studied for its potential in preventing muscular atrophy caused by sarcopenia and improving muscle mass, strength, and functional performance. However, further research is needed to investigate its effectiveness in patients with sarcopenic obesity.

The upcoming trial will be the first to explore the use of a progressive yoga technique for the management of dynapenia/sarcopenia in obese individuals.

Expected Study Outcome

Progressive yogic exercises along with standard diet is likely to result in improved muscle strength, mass and function in dynapenic/sarcopenic individuals. This in turn will be helpful in improving metabolic abnormalities such as insulin resistance and dyslipidemia. Aerobic exercises are important along with nutritional intervention and are helpful in weight loss but these are not effective in improving muscle mass and function. It may not be possible for everyone to engage in aerobic exercises of sufficient intensity. However, yogic exercises can be undertaken by individuals who can’t do aerobic exercise.

Methodology

Study population: Obese adults (20-60 years) with BMI > 25 kg/m²

Study Duration: 2 years

Intervention duration: 3 months

Study design: Interventional

Study type: Randomized Controlled Trial

Primary outcome measures: Muscle strength, skeletal muscle mass and function in obese sarcopenic individuals with above mentioned interventions.

Secondary outcome measures: Changes in body composition, metabolic parameters, insulin resistance and subclinical inflammation

Sample size: Extensive literature search was conducted but studies on similar intervention in the age group of 20-60 years was not found, thus as per feasibility it was decided to recruit 40 participants in each arm. Considering 20% drop out rate 50 patients in each group was calculated. Thus, we will take 50 subjects in each group and at least 100 subjects will be recruited in the study, more recruitment will be attempted.

Randomization: Randomization will be done into three groups using computer generated random numbers in order in which the participants agree to participate.

Inclusion and Exclusion Criteria

Inclusion Criteria:

●          Both men and women aged 20 to 60 years

●          Body Mass Index > 25 Kg/m²

●          Appendicular skeletal muscle mass/height²: Men< 7.0 kg/m², Women <5.4 kg/m²    

●          Hand grip strength- Men: <28 kg Women: <18 kg

●          SPPB ≤8 (The maximum score on the SPPB is 12)

Exclusion Criteria:

●          Known or recently diagnosed diabetes mellitus or coronary heart disease

●          Contraindication to progressive yogic training like severe neurological disorder.

●          Any severe acute or chronic illness, severe end organ dysfunction, post organ transplant

●          Known malignancy, HIV/ HBsAg/Anti HCV positivity

●          Chronic alcohol use (>30 g/day in men and >20 g/day in women) or any other drug abuse

●          Use of any medications that may affect the muscle function or mass such as corticosteroids, anabolic steroids, protein supplements, performance enhancing medications etc.

●          Pregnancy and lactation, any physical deformity or loss of extremity

Implementation strategy

Structured Yogic exercises:  The participants in Yogic exercise group will be advised to practice one hour of yogic exercise at least five days in a week. The pretested yogic exercise schedule that will be followed in the study is adopted from the similar study done previously (Rshikesan et al, 2016). The one-hour session of yoga exercises will consist of loosening exercises, suryanamaskar, asanas (postures) and pranayamas (breathing exercises) in phase 1. Once patients get comfortable in these asanas, they will then progress to other higher-level asanas. All of the major muscle groups i.e., chest, back, arms, shoulders, upper legs (quadriceps, hamstrings, and gluteal muscles), and lower legs (calves) are exercised at each exercise session. Yogic exercise which causes an increase in muscle strength and mass requires a considerable amount of upper and lower body strength. Progression in yogic asanas will be done week after week. The participants will be trained in yoga by a trained yoga instructor for approximately 1 hour daily for five days in the first week then weekly for the rest of the intervention period. To support the individual home practice, all participants will be given written handouts with photographs and DVDs, and a diary to keep track of practice time and frequency.

Standard Diet: In the form of balanced diet advice with adequate protein intake as per standard dietary recommendations comprising up to 30% of total daily energy intake and appropriate intake of micronutrients. A moderate energy restriction of 500 kcal/d will be advised targeted at a moderate weight loss of about 0.5 kg/week or 8%– 10% of initial body weight after 3 months.

Standard physical activity: A total of about 60 minutes of daily physical activity will be advised. It will include 30 minutes of aerobic activity (brisk walking/cycling/treadmill walking with moderate intensity), 15 minutes of work-related activity and 15 minutes of muscle strengthening exercises (sit-ups/push-ups and isometric strengthening of all major muscle groups). It will be advised to perform these exercises daily or at least five days in a week with a gradual progression in repetitions and intensity as tolerated by the patient.

Statistical analysis

Descriptive statistics will be used to summarize the demographic characteristics of the study population. The primary analysis will be done using appropriate statistical tests, such as t-tests or non-parametric equivalents. Adjustments for potential confounders will be performed through regression analysis if necessary.