NCT01241747已完成不适用
Exercise for Women With Peripheral Arterial Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in 6-minute walk distance
研究概览
简要总结
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group.
Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 60 years of age and older having a positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
- •exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
- •an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test
- •at least one year past menopause
排除标准
- •absence of PAD (peripheral artery disease)
- •asymptomatic PAD (Fontaine stage I)
- •rest pain due to PAD (Fontaine stage III)
- •tissue loss due to PAD (Fontaine stage IV)
- •medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
- •use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
- •cognitive dysfunction (mini-mental state examination score < 24)
- •active cancer, renal disease, or liver disease
- •a calf skin fold measurement > 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
- •pulse arterial oxygen saturation of the index finger < 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
结局指标
主要结局
Change in 6-minute walk distance
时间窗: 3 months
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
时间窗: 3 months
次要结局
- Change in peak oxygen uptake(3 months)
- Change in daily ambulatory activity(3 months)
- Change in calf muscle oxygen saturation(3 months)
- Change in walking economy(3 months)
研究者
研究点 (2)
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