Community Walking Exercise for Patients With Peripheral Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Behavioral: Exercise therapy
* Procedure: lower extremity ET
* Procedure: peripheral open intervention


Participation Criteria
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Eligibility Criteria
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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 Individuals with left bundle branch block or sustained ventricular tachycardia (>30 sec) during screening Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening; Patients can be reconsidered for study inclusion following a 1 month washout period from these medications Electrolyte abnormalities (e.g., potassium <3.3 mmol∙Lˉ1 ) Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening) Incarcerated individuals Individuals acutely impaired by alcohol or other illicit drugs Poorly controlled diabetes defined as glycated hemoglobin >12% Severely anemic patients (Hgb <11 g∙dLˉ1 for women and <10 g∙dLˉ1 for men) For patients who have not received peripheral revascularization, an ABI of >0.90 For patients with equivocal resting ABIs (0.91-0.99), a drop of <15% in the post-exercise ABI For individuals with non-compressible vessels (ABI >1.39) who have a toe- brachial index (TBI) >0.70 Inability to speak English Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise therapy<br>Claudication, no peripheral revasc | Behavioral: Exercise therapy<br>* The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).<br>|
| Placebo Comparator: Exercise advice<br>Claudication, no peripheral revasc | Behavioral: Exercise therapy<br>* The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).<br>|
| Experimental: lower extremity ET, exercise therapy<br> | Behavioral: Exercise therapy<br>* The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).<br>Procedure: lower extremity ET<br>* catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)<br>|
| Placebo Comparator: lower extremity ET, exercise advice<br> | Procedure: lower extremity ET<br>* catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)<br>|
| Experimental: Peripheral open intervention, exercise therapy<br> | Behavioral: Exercise therapy<br>* The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).<br>Procedure: peripheral open intervention<br>* revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)<br>|
| Placebo Comparator: Peripheral open intervention, exercise advice<br> | Procedure: peripheral open intervention<br>* revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak walking time (PWT) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Functional ability will be assessed with the 6-min walk test and Short Physical Performance Battery which consists of 1) walking short distances, 2) completing balance tests and 3) sit and standing from a chair 5 times. | 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 | For patients randomized to the exercise therapy group | post-12 weeks (exercise and control groups) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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claudication, community walking exercise, community-based participatory research, exercise adherence, endovascular therapy