Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 6-Minute Walking Test (mobility)
研究概览
简要总结
A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care.
This randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (SHB) compared to walking advice (WA) recommendation intended as usual care, in PAD patients.
Male and females PAD patients at Leriche-Fontaine's stage II and aged more than 60 years old will be enrolled. Patients will be randomized in SHB or WA groups.
Patients of SHB group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. The program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. Two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed.
Patients randomized in WA group will receive the advice to walk as suggested by the guidelines. In particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible.
Outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. Primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test Secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.
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)
盲法说明
Outcome assessors will be blinded to patients' allocation
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and females aged > 60 years old
- •peripheral artery disease at Leriche-Fontaine's stage 2a or 2b
- •cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.
排除标准
- •peripheral artery disease at Leriche-Fontaine's stage 1
- •peripheral artery disease at Leriche-Fontaine's stage 3 or more
- •severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV)
- •neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
- •very good exercise capacity determined by a 6-minute walking distance > 500 meters.
研究组 & 干预措施
Structured home-based exercise
Program will include two 8-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. The walking sessions will be preferably performed indoors at home or on a treadmill. During the study, 2 follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence to the program and to update the exercise program with the duration of each session that remained constant. The walking intensity of each exercise regime will be progressively modified to increase the training load. The patients will be asked to fill out a daily training record indicating completion of the exercise and any associated symptoms. Patients will have the ability to contact the rehabilitation team, composed of a physician and a sports science expert, throughout the entire study period via phone.
干预措施: Structured home-based exercise (Behavioral)
Walking advice
Patients will receive advice to walk as suggested by the guidelines. In particular, a team member will recommend patients to gather almost 30 minutes of walking at least 3 times per week; when the patient will face claudication pain, he/she will be allowed to rest, and restart walking as soon as possible. A daily log to be compiled will be provided to each patients to record the amount of walk performed.
干预措施: Walking advice (Behavioral)
结局指标
主要结局
6-Minute Walking Test (mobility)
时间窗: Change at 6-month (end of training) respect to baseline
Subjects will be instructed to walk as far as possible on a 21m walkway in 6 minutes, with their habitual walking device, with the possibility to slow down and rest if necessary. The total distance walked, the pain-free walking distance, and the perceived exertion at the end of the test will be recorded.
次要结局
- Foot temperature(Change at 6-month (end of training) respect to baseline)
- Ankle Brachial Index (hemodynamics)(Change at 6-month (end of training) respect to baseline)
- 5-time sit-to-stand test (lower limbs strength)(Change at 6-month (end of training) respect to baseline)
- Number and rate of mortality(6-month, 12-month and 24-month (follow up))
- Vascu-QoL-6 (health-related quality of life)(Change at 6-month (end of training) respect to baseline)
- Number and rate of hospitalizations(6-month, 12-month and 24-month (follow up))