NCT02310256已完成不适用
A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- absolute walking distance (meters) as measured by 6 minute walking test
研究概览
简要总结
The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with intermittent claudication secondary to vascular insufficiency
- •An ankle-brachial index between 0.4 and 0.9.
排除标准
- •Diagnosed with critical limb ischemia
- •Ankle-brachial index (ABI) > 0.90 or < 0.4
- •Limited exercise tolerance
- •Warfarin or heparin usage
- •Underwent a vascular intervention in the last 6 months
- •Active cancer, renal- or liver disease
研究组 & 干预措施
Usual care
No Intervention
Five Plus
Active Comparator
Exercise training
干预措施: Five plus exercise training (Other)
结局指标
主要结局
absolute walking distance (meters) as measured by 6 minute walking test
时间窗: 8 weeks
treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
mitochondrial function measured by respirometry
时间窗: 8 weeks
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
次要结局
- Quality of life assessed by SF 36 and CLAU-S questionnaires(8 weeks)
- Peak oxygen uptake measured by cardio-pulmonal exercise testing(8 weeks)
- Arterial bloodflow measured by plethysmography(8 weeks)
研究者
研究点 (1)
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