A Study to Estimate the Efficacy and Duration of Tailored Exercise to Improve Sarcopenia, Sarcopenic Obesity, and Myokine Levels in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity as assessed by Bioelectrical impedance analysis (BIA) and clinical measures in sarcopenic patients of rheumatoid arthritis
研究概览
简要总结
AIM:
To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity in sarcopenic patients of rheumatoid arthritis
Primary objective: To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity as assessed by Bioelectrical impedance analysis (BIA) and clinical measures in sarcopenic patients of rheumatoid arthritis
Secondary objectives:
· To estimate levels of the myokine myostatin and exerkine irisin in this population pre and post intervention
· To determine the duration needed to achieve a change in the severity of sarcopenia
· To determine disease activity (DAS 28-CRP), fatigue (FACIT-F), disability (HAQ-DI), quality of life (EQ5D5L) pre and post the intervention
· To determine the associations between sarcopenia/sarcopenic obesity, disease parameters and myokine levels
RESEARCH QUESTION: To determine the objective increase in appendicular skeletal muscle mass by Bioelectrical impedance analysis (BIA) in sarcopenic patients of rheumatoid arthritis when subjected to a tailored exercise regimen over and above standard of care
• P : Patients of diagnosed rheumatoid arthritis who have sarcopenia
• I: Tailored graded exercise regimen (Strength training/ resistance training, aerobics and flexibility)
• C: Same group after the intervention (Before and after)
• O : Objective increase in muscle mass as measured by BIA
• T: 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of diagnosed RA ACR-EULAR 2010 Criteria Sarcopenia as per AWGS criteria.
排除标准
- •1.Diagnosed cases of end stage chronic kidney disease , decompensated chronic liver disease, Heart failure, infections, COPD, interstitial lung disease with functional impairment, permanent neurological disorders, cancers, or on medication for these
- •ACR functional status class IV : Limited ability to perform usual self-care, work, and hobbies.
- •Overlap with other connective tissue disease.
结局指标
主要结局
To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity as assessed by Bioelectrical impedance analysis (BIA) and clinical measures in sarcopenic patients of rheumatoid arthritis
时间窗: 4 weeks, 8 weeks, 12 weeks, 16 weeks and 24 weeks
次要结局
- • To estimate levels of the myokine myostatin and exerkine irisin in this population pre and post intervention(• To determine the duration needed to achieve a change in the severity of sarcopenia)
研究者
Dr Varsha Bhatt
Bharati Vidyapeeth (Deemed to Be) University Medical College and Hospital ,Pune