Peripheral Artery DiseaseNCT04751890
Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial
A study testing Structured home-based exercise and Walking advice in people with Peripheral Artery Disease, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Structured home-based exercise and Walking advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Structured home-based exercise, Walking advice
- Keywords
- exercise, rehabilitation, exercise testing
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured home-based exerciseBehavioural
Low-intensity interval walking program prescribed at hospital and performed at daily at home
Walking adviceBehavioural
Walking advice according to the guidelines for peripheral artery disease patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Walking advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change at 6-month (end of training) respect to baseline
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6-month, 12-month and 24-month (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Manfredini, MD, PhD, Principal investigator, University of Ferrara and University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751890
- Sponsor's protocol ID
- 898/2020/Sper/AOUFe
- Status last verified
- May 2025
- First submitted
- 9 Feb 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published at the end of the trial after deidentification.
Publications
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.
PubMed 18503221Treat-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.
PubMed 30586765Manfredini 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.
PubMed 34068534
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04751890
- Acronym / sponsor ID
- 898/2020/Sper/AOUFe
- Conditions
- Peripheral Artery Disease
- Keywords
- exercise, rehabilitation, exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured home-based exercise | Experimental | Behavioral: Structured home-based exerciseProgram 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. |
| Walking advice | Active comparator | Behavioral: Walking advicePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured home-based exerciseLow-intensity interval walking program prescribed at hospital and performed at daily at home | Behavioural | Structured home-based exercise |
| Walking adviceWalking advice according to the guidelines for peripheral artery disease patients | Behavioural | Walking advice |
Primary outcome
6-Minute Walking Test (mobility)
Time frame: 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.
6 secondary outcomes
Ankle Brachial Index (hemodynamics)
Time frame: Change at 6-month (end of training) respect to baseline
Vascu-QoL-6 (health-related quality of life)
Time frame: Change at 6-month (end of training) respect to baseline
5-time sit-to-stand test (lower limbs strength)
Time frame: Change at 6-month (end of training) respect to baseline
Foot temperature
Time frame: Change at 6-month (end of training) respect to baseline
Number and rate of hospitalizations
Time frame: 6-month, 12-month and 24-month (follow up)
Number and rate of mortality
Time frame: 6-month, 12-month and 24-month (follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 18503221Manfredini 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.
- Background: PubMed 30586765Treat-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.
- Derived from this study: PubMed 34068534Manfredini 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published at the end of the trial after deidentification.
Related trials for Peripheral Artery Disease
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Manfredini, MD, PhD principal investigator
University of Ferrara and University Hospital of Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured home-based exercise and Walking advice in people with Peripheral Artery Disease, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walking Test (mobility) (time frame: Change at 6-month (end of training) respect to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751890, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.