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Behavioural Intervention

Telehealth-Supervised Exercise for Peripheral Arterial Disease (MOVE-IT Trial)

N/A
Recruiting
Led By Jorge Antonio Gutierrez, 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
Presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes
Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI >0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography
Must not have
Major lower extremity amputation
Inability to ambulate without a walker or wheelchair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3-months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding supervised exercise to usual care can help improve quality of life and cardiovascular risk for Veterans with PAD.

Who is the study for?
This trial is for Veterans with Peripheral Arterial Disease (PAD) who experience leg pain during exercise that goes away with rest. They must have a confirmed PAD diagnosis, be able to walk without a walker or wheelchair, and not be part of another exercise program. They need cellular signal access at home or where they'll exercise.
What is being tested?
The study tests if supervised telehealth exercise can improve walking ability, quality of life, and heart health in Veterans with PAD. Participants will do exercises while being remotely monitored to see if this method is effective.
What are the potential side effects?
Since the intervention involves exercise, potential side effects may include muscle soreness, fatigue, and discomfort related to increased physical activity. However, these are common reactions to starting an exercise regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience leg pain from walking that stops when I rest.
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I have been diagnosed with PAD based on specific tests or procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major amputation of my lower limb.
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I need a walker or wheelchair to move around.
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I have severe heart issues that limit my daily activities.
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I am not pregnant, imprisoned, a child, or unable to make decisions for myself.
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I have severe blockage in my leg arteries causing pain and ulcers.
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I have major issues with my sight or hearing.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
10 meter walk
30-sec arm curls
30-sec-chair stands
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 Intervention
Prospective pre-post pilot study design. (N=54)
Group II: No exerciseActive Control1 Intervention
Prospective cohort study design. (N=100)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,427,134 Total Patients Enrolled
13 Trials studying Peripheral Arterial Disease
1,276 Patients Enrolled for Peripheral Arterial Disease
Jorge Antonio Gutierrez, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Media Library

Exercise (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05048979 — N/A
Peripheral Arterial Disease Research Study Groups: Exercise, No exercise
Peripheral Arterial Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05048979 — N/A
Exercise (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048979 — N/A
~26 spots leftby Jun 2025
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