12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- KU Leuven
- 主要终点
- Change in heart rate pain threshold at 12 weeks of follow-up
研究概览
简要总结
Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. The aim of this randomized controlled trial which will be performed with 34 PAD women will be to investigating the effects of 12 weeks of supervised walking on functional capacity and cardiovascular function and regulation at rest and during exercise.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •aankle-brachial index (ABI) ≤ 0.9 in one or two legs
- •fontaine stage II of PAD
- •body mass index <35 kg/m2
- •resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg
- •ability to walk at least 2min at 3.2 km/h
- •ability to undertake an incremental treadmill test
- •decrease of at least 15% in ABI after a maximal treadmill test
- •not currently engaging in any regular exercise program
排除标准
- •exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
- •cardiovascular autonomic neuropathy
- •use of beta-blocker, nondihydropyridine calcium antagonists or insulin and hormone replacement therapy.
研究组 & 干预措施
Stretching exercise group
Patients will receive two session per week of stretching classes.
干预措施: Stretching exercise group (Other)
Walking training group
Patients will perform two walking sessions per week.
干预措施: Walking training group (Other)
结局指标
主要结局
Change in heart rate pain threshold at 12 weeks of follow-up
时间窗: 12 weeks
The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up.
Change in walking capacity at 12 weeks of follow-up
时间窗: 12 weeks
Claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test will be performed before and after 12 weeks of follow-up.
Change in functional capacity at 12 weeks of follow-up
时间窗: 12 weeks
Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be measured to determine the cardiopulmonary response after 12 weeks of walking training.
次要结局
- Change in autonomic modulation at 12 weeks of follow-up(12 weeks)
- Change in vascular function at 12 weeks of follow-up(12 weeks)
- Change in cardiac output at 12 weeks of follow-up(12 weeks)
- Change in Ankle-Brachial Index decrease at 12 weeks of follow-up(12 weeks)
- Change in ischemic window at 12 weeks of follow-up(12 weeks)