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

NCT04751890 | Completed

• 1 other identifier: 898/2020/Sper/AOUFe
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

exercise; rehabilitation; exercise testing

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walking Test (mobility)

  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.

  Change at 6-month (end of training) respect to baseline

Secondary Outcomes (6)

• Ankle Brachial Index (hemodynamics)

  Change at 6-month (end of training) respect to baseline

• Vascu-QoL-6 (health-related quality of life)

  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

• Foot temperature

  Change at 6-month (end of training) respect to baseline

• Number and rate of hospitalizations

  6-month, 12-month and 24-month (follow up)

Study Arms (2)

Structured home-based exercise

EXPERIMENTAL

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.

Behavioral: Structured home-based exercise

Walking advice

ACTIVE COMPARATOR

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.

Behavioral: Walking advice

Interventions

Structured home-based exercise BEHAVIORAL

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

Structured home-based exercise

Walking advice BEHAVIORAL

Walking advice according to the guidelines for peripheral artery disease patients

Walking advice

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Ferrara, 44124, Italy

Location

Related Publications (3)

• Manfredini F, Malagoni AM, Mascoli F, Mandini S, Taddia MC, Basaglia N, Manfredini R, Conconi F, Zamboni P. Training rather than walking: the test in -train out program for home-based rehabilitation in peripheral arteriopathy. Circ J. 2008 Jun;72(6):946-52. doi: 10.1253/circj.72.946.

  PMID: 18503221 BACKGROUND

• Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available.

  PMID: 30586765 BACKGROUND

• Manfredini F, Lamberti N, Traina L, Zenunaj G, Medini C, Piva G, Straudi S, Manfredini R, Gasbarro V. Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial. Methods Protoc. 2021 May 10;4(2):29. doi: 10.3390/mps4020029.

  PMID: 34068534 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• Fabio Manfredini, MD, PhD

  University of Ferrara and University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to patients' allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Individual participant data will be available beginning 6 months following study results publication.
• Access Criteria: Anyone who wishes to access the data.

Locations

IT (1)