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

Not Applicable

• Conditions: Peripheral Artery Disease

• Registration Number: NCT04751890
• Lead Sponsor: University Hospital of Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Study Start: 2021-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-Minute Walking Test (mobility)	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 Outcome Measures

Name	Time	Method
Ankle Brachial Index (hemodynamics)	Change at 6-month (end of training) respect to baseline	The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The ABI is calculated by dividing the systolic blood pressure measured at the ankle for both limbs with the patient in supine position by the systolic blood pressure in the arm.
5-time sit-to-stand test (lower limbs strength)	Change at 6-month (end of training) respect to baseline	This test consists in moving from a sitting position to a standing position on a 42- cm high chair as quick as possible, for five times, with arms folded across the chest. Time will be taken when the test starts, and when the patient lay his/her buttocks on the chair for the fifth time.
Number and rate of mortality	6-month, 12-month and 24-month (follow up)	Number and rate of all-cause mortality within participants will be collected.
Vascu-QoL-6 (health-related quality of life)	Change at 6-month (end of training) respect to baseline	This questionnaire consists of 6 items with a score ranging from 1 to 4 examining various aspects of disease-related quality of life. Higher scores correspond to better quality of life.
Number and rate of hospitalizations	6-month, 12-month and 24-month (follow up)	Number and rate of all-cause hospitalizations within participants will be collected.
Foot temperature	Change at 6-month (end of training) respect to baseline	Foot temperature will be noninvasively measured through an infrared thermal imaging camera at the dorsum of each foot at three points

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Ferrara, Italy