A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- University of Minnesota
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in peak walking time (PWT)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
Detailed Description
The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women diagnosed with atherosclerotic PAD
- •≥40 years of age
- •An abnormal ankle-brachial index (ABI) of ≤.90
- •For patients with an ABI \>.90 and \<1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
- •Patients receiving lower extremity ET or peripheral open intervention
- •Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI
Exclusion Criteria
- •Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill
- •Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
- •PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
- •Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- •Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
- •Individuals who are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute
- •Individuals who have had a myocardial infarction within 3 months prior to screening
- •Individuals who demonstrate symptoms consistent with acute coronary syndrome
- •Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ≥0.5 mm at rest and \>1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ≥1 mm)
- •Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
Outcomes
Primary Outcomes
Change in peak walking time (PWT)
Time Frame: Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period
Secondary Outcomes
- Change in claudication onset time (COT)(Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period)
- Change in patient-reported outcomes(Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period)
- Change in peak oxygen uptake(Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period)
- Change in functional ability(Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period)
- Evaluation of total volume of activity(post-12 weeks (exercise and control groups))
- Evaluation of exercise adherence(post-12 weeks (exercise and control groups))