Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 主要终点
- effectiveness:
研究概览
简要总结
Aim of the study was to investigate the effectiveness (functional ability and physical capacity) and safety (disease activity and damage of the joints) of long-term high-intensity weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be safe and effective.
详细描述
The 300 patients with RA were randomized into two groups; exercise group and usual care group. The patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and functional ability without detrimental effects on the large joints damage or on disease activity. Only patients with excessive large joint damage at baseline were at risk to develop additional damage when participating in intensive weight-bearing exercises. Patients who exercised were able to delay the decrease of bone mineral density of the hips.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis
排除标准
- •Prosthesis of a weight bearing joint
结局指标
主要结局
effectiveness:
primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months
safety:
damage of the large joints (Larsen score); each year
次要结局
- effectiveness:
- muscle strength (strength of extensors of the knee); each 3 months and
- aerobic fitness (ergometer); each 3 months
- Safety:
- disease activity (DAS) each 3 months