Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life and Cardiovascular Risk in People With Peripheral Arterial Disease (HY-PAD): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- 6MWT
研究概览
简要总结
Peripheral arterial disease (PAD), a disabling condition, affects 800,000 Canadians. People with PAD suffer from poor quality of life due to leg pain, which makes walking difficult. They also have a high risk of heart disease. In November of 2017, the University of Ottawa Heart Institute (UOHI) launched Canada's first specific walking rehabilitation and cardiovascular risk reduction program dedicated to patients with PAD.
An on-site, supervised exercise program to improve walking endurance and quality of life in PAD has been shown to be successful. However many patients are not able to participate in the on-site program due to barriers such as transportation, parking, or other commitments. Recently, a home-based walking program has also been shown to significantly improve walking endurance and quality of life among people with PAD. It was decided that a hybrid program, that has a short on-site program followed by a home-based program may allow more patients to participate and have the highest chance of success.
The goal is to develop a new hybrid program for medical care in PAD patients in order to: (a) improve their walking distance, (b) improve their quality of life and (c) improve their cardiovascular risk.
As part of this study the investigators will enrol 25 participants with PAD. Participants will be studied at baseline (before their first on-site class) and at 3 month follow up (after their last home program phone call).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent claudication with PAD documented by:
- •ABI ≤0.90 or >1.40;(14) or
- •Anatomic evidence of lower extremity arterial stenosis ≥50% (by lower extremity angiography, CT angiography, MR angiography or ultrasound)
- •Ability to participate in the study (ability to walk)
- •Willingness to provide informed consent
排除标准
- •They have had previous lower extremity amputation
- •They are unable to walk
- •They have critical limb ischemia or open lower extremity wounds.
- •Patient is unable to read and understand English or French
- •Patient is unable, in the opinion of the qualified investigator or referring physician, to comprehend and participate in the exercise intervention.
结局指标
主要结局
6MWT
时间窗: at 3 month follow up
Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months
次要结局
- Improvements in quality of life(at 3 month follow up)
- improvements in Walking Impairment Questionnaire(at 3 month follow up)