Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial

University Hospital of Ferrara

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Behavioral: Walking advice; Behavioral: Structured home-based exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04751890

898/2020/Sper/AOUFe

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Structured home-based exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Structured home-based exercise

Walking advice

Active Comparator group

Description:

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.

Treatment:

Behavioral: Walking advice