Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- University Hospital of Ferrara
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 6-Minute Walking Test (mobility)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
6-Minute Walking Test (mobility)
Time Frame: 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.
Secondary Outcomes
- 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))
- Foot temperature(Change at 6-month (end of training) respect to baseline)