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Mobile Health-Supported Exercise Therapy for Peripheral Artery Disease (Smart MOVE Trial)

N/A
Recruiting
Led By Arash Harzand, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >40 years
Established PAD diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
Must not have
Non-English speaking
Unstable atrial or ventricular arrhythmias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Summary

This trial will investigate whether home-based exercise therapy (HBET) delivered through mobile health technologies can help Veterans with peripheral artery disease (PAD).

Who is the study for?
This trial is for Veterans over 40 with Peripheral Arterial Disease (PAD) who have stable symptoms and can safely walk. They must not be involved in other trials or structured exercise programs, need to speak English, and should not have conditions like critical limb ischemia, recent major surgeries, severe heart issues, active substance abuse that affects participation, or mental health illnesses that could interfere with the study.
What is being tested?
The study tests a home-based exercise therapy using mobile health tech for Veterans with PAD. It involves group coaching and an activity monitor as part of Smart MOVE!, aiming to improve walking ability without the inconvenience of facility-based programs.
What are the potential side effects?
Since this trial focuses on exercise therapy through walking advice and monitoring rather than medication or invasive procedures, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 40 years old.
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I have been diagnosed with PAD based on specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I do not have irregular heartbeats that are unstable.
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I have inflammation of the heart and its surrounding sac.
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I cannot walk without the help of a walker.
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I have a severe heart block without a pacemaker.
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I use a wheelchair for mobility.
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I do not have any active heart conditions like unstable angina.
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I have a condition like Parkinson's that affects my ability to walk.
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My walking is limited due to a condition that is not peripheral artery disease.
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I haven't had major surgery in the last 3 months and don't plan any in the next 9 months.
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I have severe leg pain at rest or wounds that won't heal.
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I have had an amputation above or below the knee.
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My vision problems make it hard for me to walk.
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I have had a blood clot in a vein recently.
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I have severe heart failure or chest pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-minute walk test

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Performance evaluationExperimental Treatment1 Intervention
Preliminary performance evaluation to refine the Smart MOVE! intervention.
Group II: Smart MOVE!Active Control1 Intervention
Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.
Group III: Usual carePlacebo Group1 Intervention
Participants will receive general walking advice for 12 weeks.

Find a Location

Who is running the clinical trial?

LifeQ B.V.UNKNOWN
LifeQUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,995 Total Patients Enrolled
13 Trials studying Peripheral Arterial Disease
1,383 Patients Enrolled for Peripheral Arterial Disease

Media Library

Exercise Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04889105 — N/A
Peripheral Arterial Disease Research Study Groups: Performance evaluation, Smart MOVE!, Usual care
Peripheral Arterial Disease Clinical Trial 2023: Exercise Therapy Highlights & Side Effects. Trial Name: NCT04889105 — N/A
Exercise Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889105 — N/A
~26 spots leftby Mar 2026