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

Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Structured home-based exercise; Behavioral: Walking advice

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Structured home-based exercise; Low-intensity interval walking program prescribed at hospital and performed at daily at home
Active Comparator: 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.	Behavioral: Walking advice; Walking advice according to the guidelines for peripheral artery disease patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Brachial Index (hemodynamics)	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.	Change at 6-month (end of training) respect to baseline
Vascu-QoL-6 (health-related quality of life)	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.	Change at 6-month (end of training) respect to baseline
5-time sit-to-stand test (lower limbs strength)	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.	Change at 6-month (end of training) respect to baseline
Foot temperature	Foot temperature will be noninvasively measured through an infrared thermal imaging camera at the dorsum of each foot at three points	Change at 6-month (end of training) respect to baseline
Number and rate of hospitalizations	Number and rate of all-cause hospitalizations within participants will be collected.	6-month, 12-month and 24-month (follow up)
Number and rate of mortality	Number and rate of all-cause mortality within participants will be collected.	6-month, 12-month and 24-month (follow up)

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Principal Investigator: Fabio Manfredini, MD, PhD, University of Ferrara and University Hospital of Ferrara

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; exercise testing
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 898/2020/Sper/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results published at the end of the trial after deidentification.
• IPD Sharing Time Frame: Individual participant data will be available beginning 6 months following study results publication.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No