Screening Postmenopausal Women For Sarcopenia Risk:A Randomised Controlled Trial Comparing Functional Task Oriented Training Versus Conventional Treatment On Muscle Strength,Fatigue,Functional Outcomes And Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The study procedure will involve screening and recruiting postmenopausal women aged 50 to 65 years who are at risk of sarcopenia from Department of community physiotherapy, school of physiotherapy Sangli. After initial screening using standard criteria like the Asian Working Group for Sarcopenia guidelines and obtaining informed consent, participants will undergo baseline assessments including estrogen levels (estradiol) to confirm the post-menopausal status and other measures of muscle strength, fatigue, functional outcomes based on the ICF framework, inflammatory biomarkers, and peak expiratory flow rate. Participants will then be randomized into two groups: one receiving a 12-week Functional Task-Oriented Training program tailored to improve daily functional movements, and the other receiving conventional physiotherapy treatment. Throughout the intervention, adherence and safety will be closely monitored, with adverse events managed promptly. Post-intervention assessments identical to the baseline will be conducted by blinded evaluators to determine changes in the outcome measures. Data will be securely managed and analysed to compare the effect of both interventions on enhancing muscle strength, reducing fatigue, improving function, and modulating biomarkers, ensuring a comprehensive understanding of the intervention’s effectiveness in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 50–65 years who have experienced amenorrhea for at least 12 months, confirmed by blood tests showing low estrogen levels.
- •Pre-sarcopenia or risk of sarcopenia based on AWGS 2019 criteria (low muscle mass or strength without severe mobility loss) having a score of SARC-CalF more than or equal to
- •Ambulatory, able to walk independently without assistive devices
- •Stable medical condition and not on anti-inflammatory or hormonal therapy in the past 6 months
- •Willing to provide informed consent and comply with intervention and follow-ups.
排除标准
- •1- severe cardiopulmonary, renal, hepatic or neurological disorders affecting exercise participation 2- recent fractures or orthopedic surgery or severe arthritis limiting mobility 3- current hormone replacement therapy or long term corticosteroid use 4- active malignancy, autoimmune, or chronic inflammatory disease.
- •5-uncontrolled diabetes or hypertension.
- •6- participation in regular resistance training.
- •7- cognitive impairement or psychiatric illness limiting compliance.
研究者
Dr Jinal Porwal
Bharati Vidyapeeth School of Physiotherapy, Sangli