Status:
RECRUITING
Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types o...
Detailed Description
The objective of this study is to evaluate two delivery methods of home-based walking among Veterans with PAD. The investigators will use an innovative sequential multiple assignment, randomized trial...
Eligibility Criteria
Inclusion
- Men and women
- Diagnosis of lower extremity PAD due to atherosclerosis
- Claudication with walking defined as stage 1-3 on the Rutherford Scale
- Medical clearance from the patient's primary care provider or vascular care provider
- Ability to walk at least one city block
- Self-reported sedentary behaviors defined as \< 150 minutes per week of physical activity
- Access to a phone and/or email \& Internet
- Competent to provide informed consent
Exclusion
- Life expectancy of less than six months
- Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)
- Resident of a nursing home
- Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise
- Planned revascularization or amputation in the next two months
- Recent CVD events (\< 3 months) including stroke/TIA, MI, UA, PCI/CABG
- Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias)
- Current substance abuse
- Psychiatric disorder which limits the patient's ability to follow the study protocol
- Pregnancy
- Inability to speak and read English
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2027
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06033924
Start Date
July 1 2024
End Date
October 29 2027
Last Update
April 18 2025
Active Locations (3)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
2
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
3
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211