Effects of a Group-based Exercise and Educational Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
研究概览
简要总结
The purpose of this study is to evaluate the effects of a group-based exercise and educational program for people with Rheumatoid Arthritis (RA) on physical performance and disease-self-management.
详细描述
Currently, the effectiveness of a program consisting of education to improve disease self-management combined with intensive exercises is not clear. In the present study the investigators developed a group-based program for people with RA consisting of physical exercise to increase physical performance (i.e. aerobic capacity and muscle strength) combined with an educational program to improve disease self-management (self-reported health status and self-efficacy). The investigators called it the 'FIT program'. The aim of the present randomized controlled trial (RCT) was to examine the effects of the FIT program on aerobic capacity, muscle strength, self-reported health status and self-efficacy, in a population of people with RA. The investigators hypothesized that the FIT-program would have beneficial effects on physical performance (ie. aerobic capacity and muscle strength) and disease self-management (i.e. perceived health status and self-efficacy components) compared to a waiting list control group (WLCgroup).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria
- •between 18 and 66 years of age
排除标准
- •severe disease activity (Disease Activity Score:DAS-28 > 5.1)
- •cardiac or pulmonary diseases resulting in restrictions in their ability to follow a physical exercise program
- •a Steinbrocker classification of functional capacity in RA ≥ 3
- •no stable medication for the RA
- •intra-articular injections during the time of the study
研究组 & 干预措施
fit-program
Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
干预措施: experimental Fit-program (Other)
waiting list control group
The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
干预措施: no intervention (Other)
结局指标
主要结局
Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness
时间窗: baseline, postintervention at 9 weeks
maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from \< 21( sedentary with disease) to \> 57 ( very good physical condition).
次要结局
- Change in Self-efficacy Pain and Other Symptoms(baseline, postintervention at 9 weeks,)
- Change in Muscle Strength of the Lower Extremity(baseline, postintervention at 9 weeks,)
- Change in Self-efficacy Function(baseline, postintervention at 9 weeks,)
- Change in Muscle Strength of the Upper Extremity(baseline, postintervention at 9 weeks,)
- Change in Health Status: Psychological Health(baseline, postintervention at 9 weeks,)
- Change in Health Status: Social Interaction(baseline, postintervention at 9 weeks,)
- Change in Health Status: Physical Health(baseline, postintervention at 9 weeks,)