Peripheral Artery DiseaseSmart MOVENCT04889105
Exercise Therapy for PAD Using Mobile Health
A study testing Smart MOVE!, General walking advice and Performance evaluation in people with Peripheral Artery Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Smart MOVE!, General walking advice and Performance evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible Veteran status
- Clinically stable intermittent claudication (2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
- Established peripheral artery disease (PAD) diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
- Access to safe location to perform walking exercises
Who cannot join
- Above or below knee amputation
- critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)
- inability to walk without a walker
- wheelchair confinement
- non-English speaking
- significant visual impairment that interferes with walking activity
Show all 32Show fewer
- hearing impairment that interferes with full study participation
- unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention
- Individuals whose walking is limited by a condition other than peripheral artery disease (PAD)
- Any active cardiac condition including unstable angina
- unstable atrial or ventricular arrhythmias
- high-grade heart block without a pacemaker
- active myopericarditis
- recent venous thromboembolism
- or recent abnormal baseline stress test suggesting ischemia
- other high-risk findings (e.g., drop of systolic blood > 20 millimetres of mercury (mmHg) with exercise)
- Presence of Class III NYHA heart failure or CCS III angina
- Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
- Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)
- neurodegenerative disorders such as Parkinson's Disease that impair walking ability
- cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)
- Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months
- Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score <24
- dementia
- active psychiatric disorder such as schizophrenia or bipolar disorder
- history of suicidal or homicidal ideation in the preceding six months
- history of suicidal attempts in the preceding 12 months
- history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)
- Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
- Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)
- Deemed to be poorly suited for the study or the study intervention at the discretion of the principal investigator (PI) or study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
About this study
Official title: Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.
Read the detailed description
An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors.
Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic.
A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD.
This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.
- Conditions
- Peripheral Artery Disease
- Being tested
- Smart MOVE!, General walking advice, Performance evaluation
- Keywords
- Mobile health, Telemedicine, Peripheral artery disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart MOVE!Behavioural
Multi-component behavioral intervention of PAD consisting of:
- guideline-directed HBET prescription
- active behavioral coaching (via MOVE! program or other)
- mobile health monitoring
General walking adviceBehavioural
Basic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.
Performance evaluationBehavioural
Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include:
- Provider and stakeholder interviews
- PAD patient interviews
- N-of-1 trials to refine the intervention
| Study group | Role | What they receive |
|---|---|---|
| Performance evaluation | Other | Preliminary performance evaluation to refine the Smart MOVE! intervention. Receives: Behavioral: Performance evaluation |
| Smart MOVE! | Active comparator | Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks. Receives: Behavioral: Smart MOVE! |
| Usual care | Placebo comparator | Participants will receive general walking advice for 12 weeks. Receives: Behavioral: General walking advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6MWT)
The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in peripheral artery disease (PAD). Participants will be asked to walk back and forth along a 100-foot hallway for six minutes using standard methods and have their total distance recorded
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Dec 2021
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomized to Smart MOVE! vs. usual care using block randomization. Randomization will be stratified by baseline 6MWT performance using computer-generated blocks of 2, 4, and 6 to reduce imbalance. A blinded assessor will perform baseline assessment before randomization with condition assignments concealed in prepared envelopes that will be opened after all assessments are completed. Based on the nature of the intervention, it is not feasible to blind participants to their allocation status following randomization or study staff measuring post-assessment outcomes as both the PI and study staff are involved in delivering the intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- LifeQ
- Responsible party
- Sponsor
- Investigators
- Arash Harzand, MD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889105
- Sponsor's protocol ID
- E3546-W
- Other IDs
- 1IK2RX003546-01A2
- Acronym
- Smart MOVE
- Status last verified
- Sep 2026
- First submitted
- 11 May 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring
- ClinicalTrials.gov ID
- NCT04889105
- Acronym / sponsor ID
- Smart MOVE / E3546-W
- Conditions
- Peripheral Artery Disease
- Keywords
- Mobile health, Telemedicine, Peripheral artery disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- LifeQ
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 May 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.
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.
Detailed description
An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors.
Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic.
A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD.
This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Patients will be randomized to Smart MOVE! vs. usual care using block randomization. Randomization will be stratified by baseline 6MWT performance using computer-generated blocks of 2, 4, and 6 to reduce imbalance. A blinded assessor will perform baseline assessment before randomization with condition assignments concealed in prepared envelopes that will be opened after all assessments are completed. Based on the nature of the intervention, it is not feasible to blind participants to their allocation status following randomization or study staff measuring post-assessment outcomes as both the PI and study staff are involved in delivering the intervention.
| Arm | Type | Receives |
|---|---|---|
| Performance evaluation | Other | Behavioral: Performance evaluationPreliminary performance evaluation to refine the Smart MOVE! intervention. |
| Smart MOVE! | Active comparator | Behavioral: Smart MOVE!Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks. |
| Usual care | Placebo comparator | Behavioral: General walking adviceParticipants will receive general walking advice for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible Veteran status
- Clinically stable intermittent claudication (2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
- Established peripheral artery disease (PAD) diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
- Access to safe location to perform walking exercises
Key exclusion criteria (32 listed)
- Above or below knee amputation
- Individuals whose walking is limited by a condition other than peripheral artery disease (PAD)
- Any active cardiac condition including unstable angina
- Presence of Class III NYHA heart failure or CCS III angina
- Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
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 |
|---|---|---|
| Smart MOVE!Multi-component behavioral intervention of PAD consisting of: 1. guideline-directed HBET prescription 2. active behavioral coaching (via MOVE! program or other) 3. mobile health monitoring | Behavioural | Smart MOVE! |
| General walking adviceBasic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching. | Behavioural | Usual care |
| Performance evaluationPreliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include: 1. Provider and stakeholder interviews 2. PAD patient interviews 2) N-of-1 trials to refine the intervention | Behavioural | Performance evaluation |
Primary outcome
6-minute walk test (6MWT)
Time frame: 90 days
The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in peripheral artery disease (PAD). Participants will be asked to walk back and forth along a 100-foot hallway for six minutes using standard methods and have their total distance recorded
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Arash Harzand, MD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart MOVE!, General walking advice and Performance evaluation in people with Peripheral Artery Disease, run by VA Office of Research and Development at 1 site in United States.
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 4 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 walk test (6MWT) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.