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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
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
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.
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Who is running the clinical trial?
LifeQ B.V.UNKNOWN
LifeQUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,708 Total Patients Enrolled
13 Trials studying Peripheral Arterial Disease
1,354 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I have a safe place to walk for exercise.I do not have irregular heartbeats that are unstable.I have inflammation of the heart and its surrounding sac.You recently had a stress test that showed a problem with blood flow to your heart.You have trouble hearing that makes it hard for you to fully take part in the study.I cannot walk without the help of a walker.I have a severe heart block without a pacemaker.You have a mental health condition that could make it hard for you to understand the study or give your consent to participate.I have been treated for cancer, excluding non-melanoma skin cancer, in the last 2 years.If you have thoughts of self-harm or harming others, you may still be able to participate if your mental health provider agrees and you are closely monitored.I use a wheelchair for mobility.I do not have any active heart conditions like unstable angina.I have a condition like Parkinson's that affects my ability to walk.My walking is limited due to a condition that is not peripheral artery disease.You have a current mental health condition like schizophrenia or bipolar disorder.I have not had a heart attack, stroke, or heart surgery in the last 3 months.You are currently exercising regularly at a similar level to the exercise recommended in the study.You have thought about harming yourself or someone else in the last six months.You have tried to harm yourself in the past year.I am over 40 years old.You have dementia.I have stable leg pain when walking for 2 months without severe limb risk.I haven't had major surgery in the last 3 months and don't plan any in the next 9 months.I have severe leg pain at rest or wounds that won't heal.I have had an amputation above or below the knee.My vision problems make it hard for me to walk.I have had a blood clot in a vein recently.You have other risky health conditions, like a big drop in blood pressure during exercise.I have severe heart failure or chest pain.I do not need oxygen all the time, except possibly at night.I have been diagnosed with PAD based on specific tests.
Research Study Groups:
This trial has the following groups:- Group 1: Performance evaluation
- Group 2: Smart MOVE!
- Group 3: Usual care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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