Exercise Rehabilitation of Younger and Older People With Claudication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.
研究概览
简要总结
The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.
详细描述
Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of intermittent claudication
- •Exercise tolerance limited by intermittent claudication during a screening treadmill test
- •Ankle/brachial index (ABI) at rest less than 0.90
- •Live independently at home
排除标准
- •Absence of PAD (peripheral artery disease)
- •Asymptomatic PAD (Fontaine stage I)
- •Rest pain PAD (Fontaine stage III)
- •Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
- •Active cancer, renal disease, or liver disease
- •Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication
结局指标
主要结局
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.
时间窗: 6 months
次要结局
- Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.(6 months)