Community Walking Exercise for Patients With Peripheral Artery Disease

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Behavioral: Exercise therapy; Procedure: peripheral open intervention; Procedure: lower extremity ET

• Registration Number: NCT02075502
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise advice	Exercise therapy	Claudication, no peripheral revasc
Peripheral open intervention, exercise therapy	peripheral open intervention	-
Peripheral open intervention, exercise advice	peripheral open intervention	-
lower extremity ET, exercise therapy	Exercise therapy	-
lower extremity ET, exercise therapy	lower extremity ET	-
Exercise therapy	Exercise therapy	Claudication, no peripheral revasc
lower extremity ET, exercise advice	lower extremity ET	-
Peripheral open intervention, exercise therapy	Exercise therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.
Evaluation of total volume of activity	post-12 weeks (exercise and control groups)
Evaluation of exercise adherence	post-12 weeks (exercise and control groups)	For patients randomized to the exercise therapy group

Trial Locations

Locations (1)

International Heart Institute of Montana Foundation; 🇺🇸 Missoula, Montana, United States