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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors will be blinded to patients' allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Structured home-based exercise

Intervention Type BEHAVIORAL

Low-intensity interval walking program prescribed at hospital and performed at daily at home

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.

Group Type ACTIVE_COMPARATOR

Walking advice

Intervention Type BEHAVIORAL

Walking advice according to the guidelines for peripheral artery disease patients

Interventions

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Structured home-based exercise

Low-intensity interval walking program prescribed at hospital and performed at daily at home

Intervention Type BEHAVIORAL

Walking advice

Walking advice according to the guidelines for peripheral artery disease patients

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No