RECRUITING

Exercise Therapy for PAD Using Mobile Health

Conditions

Peripheral Artery Disease Mobile health Telemedicine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring

Quick Facts

Study Start:2021-12-01

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04889105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age \>40 years * Eligible Veteran status * Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia) * Established 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	* 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 * 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 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 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 PI or study staff

Inclusion Criteria

Exclusion Criteria

* Age \>40 years
* Eligible Veteran status
* Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
* Established 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

* 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
* 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 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 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 PI or study staff

Contacts and Locations

Study Contact

Arash Harzand, MD

CONTACT

(404) 321-6111

Arash.Harzand@va.gov

Principal Investigator

Arash Harzand, MD

PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Study Locations (Sites)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Arash Harzand, MD, PRINCIPAL_INVESTIGATOR, Atlanta VA Medical and Rehab Center, Decatur, GA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-12-01

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Mobile health
Telemedicine
Peripheral artery disease

Additional Relevant MeSH Terms

Peripheral Artery Disease