Clinical trial NCT02075502: Community Walking Exercise for Patients With Peripheral Artery Disease
Official title: A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: claudication
community walking exercise
community-based participatory research
exercise adherence
endovascular therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-03
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in peak walking time (PWT)
timeFrame: 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:
measure: Change in claudication onset time (COT)
timeFrame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
measure: Change in patient-reported outcomes
timeFrame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
measure: Change in peak oxygen uptake
timeFrame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
measure: Change in functional ability
timeFrame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
measure: Evaluation of total volume of activity
timeFrame: post-12 weeks (exercise and control groups)
measure: Evaluation of exercise adherence
timeFrame: post-12 weeks (exercise and control groups)
Other outcomes:
Locations:
city: Missoula
country: United States
facility: International Heart Institute of Montana Foundation
state: Montana
Study officials:
affiliation: International Heart Institute of Montana Foundation
name: Ryan J. Mays, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: