Efficacy of 6-month Holistic Ayurveda Intervention on Sarcopenia Related Clinical and Biochemical Outcomes among Elderly: A Multicentric Randomised Controlled Trial.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 222
- 试验地点
- 3
- 主要终点
- Short Physical Performance Battery (SPPB): The Short Physical Performance Battery (SPPB) is an assessment tool that evaluates lower limb function through three components: balance tests, gait speed assessment, and chair rise exercises. Diminished SPPB scores suggest reduced physical capability and have been associated with sarcopenia—a condition characterized by loss of muscle mass and strength—as well as other negative health outcomes.
概览
简要总结
Sarcopenia, characterized by age-related muscle loss in quantity as well as quality, is reflected as diminished muscle function that results in poor physical performance as it becomes more severe. This condition affects 12.6% to 17.5% of elderly Indians. There is piling up evidence of sarcopenia and its association with geriatric syndromes like frailty that further lead to disability, falls, adverse health outcomes,poor quality of life,increased hospitalizations, and all cause mortality among the elderly population. Sarcopenia is identified as a substantial public health burden in the geriatric population. As per the Asian Working Group for Sarcopenia (AWGS) 2019 Consensus Guidelines, there is no standard pharmacological treatment for the same. Due to the paucity of standard treatment guidelines for sarcopenia, globally, lifestyle interventions, exercise, and nutritional advice are considered mainstays. AWGS also recommends exploring treatment modalities among Asians. With the rising burden of sarcopenia in India, tailored strategies are needed that integrate culturally accepted modalities like Ayurveda, offering a holistic solution with a backup of robust scientific evidence that is subsequently globally acceptable.
- Novelty: The proposed study will be the first of its kind to investigate the effects of an Ayurvedic intervention on clinical outcomes in Sarcopenia. This will also be a novel study that investigates the effect of traditional Indian medicine on the pathophysiological mechanisms and biomarkers of Sarcopenia. Objectives: Primary: To determine the effect of 6-month Ayurveda intervention on key outcomes of Sarcopenia, i.e., muscle strength, physical performance, and appendicular skeletal muscle mass (ASM). Secondary: To determine change in Sarcopenia related inflammatory and oxidative stress markers, QOL, sleep quality, frailty and other psycho-cognitive parameters. Methods: In a multicentric randomised controlled trial, elderly individuals diagnosed with Sarcopenia (as per the AWGS 2019 guidelines) will be enrolled from three institutions. Baseline investigations of muscle strength, physical performance, ASM, inflammatory and oxidative stress markers, and questionnaires like SARC-F, FAST, ACE-III, MoCA, MNA, SarQOL, PSQI, GDS will be assessed. After randomization, the experimental arm will undergo a 6-month holistic Ayurveda intervention composed of Shashtika Shalli Pinda Sweda (SSPS) and Ashwagandha Churna Rasayana along with standard care, i.e., Risk reduction counselling including dietary advice and resistance exercise training for Sarcopenia, while the control arm will undergo standard care alone. Participants will be called for revisits on a monthly basis as per the strategic intervention plan. All participants will be followed up for 6 months, after which all the outcomes will be re-assessed.
Expected Outcomes: At the end of the trial, we expect a 20% improvement in the primary outcomes following the 6-month holistic ayurveda intervention, namely: muscle strength, physical performance, ASM. Sarcopenia related biochemical investigations of inflammatory and oxidative stress markers, QOL, sleep quality, frailty and other cognitive, psychological, and old-age related parameters are also expected to improve. Positive outcomes may pave the way for the standardisation of proposed intervention and help develop evidence-based recommendations for incorporating Ayurveda in the management of sarcopenia and other musculoskeletal issues related to old age, guiding clinical practice towards the use of evidence-based AYUSH protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Older adults greater than 60 years old, both males and females, and able to walk independently.
- •Having SARC-F scores greater than 4 Having a smartphone and proficient in using a smartphone.
- •Willing to provide written informed consent and willing to comply with study procedures.
排除标准
- •Known cases of chronic kidney disease, chronic liver disease, primary, malignancy, osteoarthritis, HIV, on ICD and stroke.
- •Diagnosed cases of psychiatric disorders like severe depression, or any psychiatric illness that impairs interaction with others.
- •Active bacterial infections or sepsis as per IDSA guidelines , Cases of exfoliative Skin infections.,Recent trauma, fractures, Major surgeries (CABG, lower limb hip or knee replacement, renal transplants ) ,musculoskeletal pains or any dysfunction that prevents exercise.
- •Subjects on anabolic steroids, glucocorticoids, chemotherapy, antituberculosis drugs and thyroxine.
- •Known contraindications for SSPS as per Ayurveda texts.
结局指标
主要结局
Short Physical Performance Battery (SPPB): The Short Physical Performance Battery (SPPB) is an assessment tool that evaluates lower limb function through three components: balance tests, gait speed assessment, and chair rise exercises. Diminished SPPB scores suggest reduced physical capability and have been associated with sarcopenia—a condition characterized by loss of muscle mass and strength—as well as other negative health outcomes.
时间窗: baseline; months 1,2,3,4,5,6 (endpoint)
次要结局
- Muscle Strength (Handgrip Strength):(Muscle strength will be assessed using a handheld dynamometer. Handgrip strength is a simple and commonly used measure of upper-extremity muscle strength, typically measured using a handheld dynamometer. Handgrip strength is associated with overall muscle strength and is a reliable indicator of functional status in older adults. Low handgrip strength is associated with an increased risk of disability, falls, and mortality. It is considered a key parameter in the diagnosis of sarcopenia.)
- Physical Performance:(6-Metre Walk Test: Walking speed is a strong predictor of functional decline and mortality in older adults. Slower walking speed suggests compromised physical performance and may indicate the presence of sarcopenia. It is measured by the time taken to walk a distance of 6 metres at a usual level pace. A walking speed of less than 1.0 m/s is associated with sarcopenia. A sub-group of participants at AIIMS Rishikesh will undergo GAIT analysis using ProtoKinetics’ Zeno Walkway Gait Analysis System.)
- Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire: SARC-F is a screening tool for sarcopenia in older adults, assessing strength (S), assistance walking (A), rising from a chair (R), climbing stairs (C), and falls (F).(baseline; months 1,2,3,4,5,6 (endpoint))
- Frailty Assessment and Screening Tool (FAST): FAST is a validated scale developed for assessing frailty among older adults, particularly in low- and middle-income countries like India. It underwent a rigorous development process and demonstrates strong psychometric properties, including high reliability and validity.(baseline; months 1,2,3,4,5,6 (endpoint))
- Liver Function Test (LFT), Kidney Function Test (KFT)(baseline; 1 month, 3 month, 6 month (endpoint))
- Montreal Cognitive Assessment (MoCA): The MoCA test is a brief screening tool used to detect mild cognitive impairment and early dementia in elderly populations. It assesses various cognitive domains including memory, attention, language, visuospatial skills, executive function, and orientation.(baseline; months 1,2,3,4,5,6 (endpoint))
- Mini Nutritional Assessment (MNA): The MNA is a screening tool designed to assess the nutritional status of older adults, aiding in the early detection of malnutrition or the risk of malnutrition.(baseline; months 1,2,3,4,5,6 (endpoint))
- SarQOL (Sarcopenia and Quality of Life): The SarQOL is a tool designed to measure the impact of sarcopenia on the quality of life in older adults.(baseline; months 1,2,3,4,5,6 (endpoint))
- Pittsburgh Sleep Quality Index(baseline; months 1,2,3,4,5,6 (endpoint))
- Geriatric Depression Scale(baseline; months 1,2,3,4,5,6 (endpoint))
- Appendicular Skeletal Muscle Mass (ASM): Appendicular skeletal muscle mass (ASM) will be measured using bioelectrical impedance analysis (BIA), which is an essential tool for assessing muscle mass.(baseline; months 1,2,3,4,5,6 (endpoint))
- Oxidative Stress(MDA, GSH-PX, SOD, eNOS, XO, Irisin, Myostatin, TGF-B1, GDF-15), Inflammatory markers using multiplex kit(Baseline; End of 6th month(endpoint))
- Addenbrooke Cognitive Examination(baseline; months 1,2,3,4,5,6 (endpoint))
研究者
Monika Pathania
All India Institute of Medical Sciences - Rishikesh