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临床试验/CTRI/2025/07/092078
CTRI/2025/07/092078
尚未招募
不适用

Effect of Yoga Intervention on Functional Performance in Elderly with Sarcopenia: A Prospective Randomized Controlled Trial

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年10月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
92
试验地点
1
主要终点
Physical Performance

概览

简要总结

The study will be conducted in 2 phases. Phase 1 will be a pilot study to check the feasibility of the intervention. In the first year of the trial, necessary approvals from the ethics committee will be obtained, the trial will be prospectively registered with CTRI, and required equipment will be procured. Participant recruitment will begin, where each eligible participant will be screened based on eligibility criteria at the study settings, informed consent will be obtained, and baseline data will be collected. The participant will then undergo a three-month intervention with regular monitoring and follow ups to ensure adherence. Data will be collected at Day 0 (baseline), Day 45 (midpoint), and Day 90 (post-intervention) to assess changes throughout the intervention. This process will continue throughout the second and third years until the required sample size is achieved. Simultaneously data collection, monitoring and follow up will be ongoing. In the final year, the complete dataset will undergo statistical analysis, results will be interpreted, and findings will be disseminated through publications and conference presentations.

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 70.00 Year(s)(—)

入选标准

  • Age Group/Gender- 60 to 70 yr, Male & Female
  • Having SARC-F score greater or equal to 4 (possible sarcopenia) and sarcopenia, as per the AWGS 2019 community guidelines
  • Subjects practicing less than 150 min.
  • of exercise per week
  • Willing to comply with the study procedures and provide a written informed consent.

排除标准

  • Known cases of chronic kidney disease, chronic liver disease, primary malignancy, osteoarthritis, uncontrolled diabetes ,uncontrolled hypertension, HIV, on ICD and stroke.
  • Diagnosed cases of psychiatric disorders like severe depression, schizophrenia.
  • Active infections or sepsis.
  • Recent trauma, fractures, major surgeries (CABG, lower limb hip or knee replacement, renal transplants ), musculoskeletal pains or any dysfunction that prevents physical activity.
  • Subjects on anabolic steroids, glucocorticoids, chemotherapy, antituberculosis drugs and thyroxine.

结局指标

主要结局

Physical Performance

时间窗: Day 0 (baseline), Day 45 (midpoint), | and Day 90 (post-intervention)

Evaluated by Short Physical Performance Battery (SPPB)

时间窗: Day 0 (baseline), Day 45 (midpoint), | and Day 90 (post-intervention)

次要结局

  • Cognitive Assessment:(MoCA questionnaire: Montreal Cognitive assessment questionnaire based)
  • Quality of Life: Questionnaire based assessment of quality of life, using Sarcopenia related(quality of life (SarQoL) questionnaire)
  • Muscle Mass: Appendicular skeletal muscle mass (ASM) measured via bioelectrical(impedance analysis (BIA))
  • Muscle Strength: Maximum grip strength measured using a calibrated hand dynamometer.(Day 0 (baseline), Day 45 (midpoint),)
  • Muscle Stem cell activation:(Concentration of PAX7 & MYF5 protein (ng/mL) in serum, measured via ELISA)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sumit

AIIMS Rishikesh

研究点 (1)

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