The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
This study will evaluate if the combination of resistance exercise and protein supplementation will increase muscle strength and muscle mass among older individuals with rheumatoid arthritis (RA).
详细描述
This study proposes a randomized trial to evaluate a tailored 16-week resistance exercise program, in combination with protein supplementation, for older individuals with RA. The exercise protocol in this study is distinctive because it combines dynamic and isometric (static) resistance exercise performed on specialized equipment that can accommodate the range of motion limitations frequently encountered in the older RA population. This study will also begin to evaluate if additional benefit can be achieved with daily protein supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 60-95 years
- •diagnosis of rheumatoid arthritis
- •willing to participate in twice weekly exercise sessions
排除标准
- •cognitive impairment
- •recent heart surgery (within past 12 months)
- •severe kidney disease
- •use of supplemental oxygen
- •presence of pacemaker
- •diabetes that requires insulin for management
- •allergy to soy or milk
研究组 & 干预措施
Carbohydrate supplement
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).
干预措施: Carbohydrate (Placebo) (Dietary Supplement)
Carbohydrate supplement
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).
干预措施: Resistance Exercise Program (Other)
Protein Supplementation
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).
干预措施: Protein (Dietary Supplement)
Protein Supplementation
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).
干预措施: Resistance Exercise Program (Other)
结局指标
主要结局
Body composition
时间窗: after 16 weeks
measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Muscle strength
时间窗: after 16 weeks
measured by hand grip and biodex
次要结局
未报告次要终点