Community Walking Exercise for Patients With Peripheral Artery Disease

NCT ID: NCT02075502

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-01
• Study Completion Date: 2020-02-12

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise therapy

Claudication, no peripheral revasc

Group Type: EXPERIMENTAL

Exercise therapy

Intervention Type: BEHAVIORAL

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 (+).

Exercise advice

Claudication, no peripheral revasc

Group Type: PLACEBO_COMPARATOR

Exercise therapy

Intervention Type: BEHAVIORAL

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 (+).

lower extremity ET, exercise therapy

Group Type: EXPERIMENTAL

Exercise therapy

Intervention Type: BEHAVIORAL

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 (+).

lower extremity ET

Intervention Type: PROCEDURE

catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)

lower extremity ET, exercise advice

Group Type: PLACEBO_COMPARATOR

lower extremity ET

Intervention Type: PROCEDURE

catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)

Peripheral open intervention, exercise therapy

Group Type: EXPERIMENTAL

Exercise therapy

Intervention Type: BEHAVIORAL

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 (+).

peripheral open intervention

Intervention Type: PROCEDURE

revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)

Peripheral open intervention, exercise advice

Group Type: PLACEBO_COMPARATOR

peripheral open intervention

Intervention Type: PROCEDURE

revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)

Interventions

Exercise therapy

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 (+).

Intervention Type: BEHAVIORAL

lower extremity ET

catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)

Intervention Type: PROCEDURE

peripheral open intervention

revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan J. Mays, PhD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

International Heart Institute of Montana Foundation

Locations

International Heart Institute of Montana Foundation

Missoula, Montana, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.nhlbi.nih.gov/

Click here for more information about the sponsor.

http://www.nih.gov/

Click here for more information about the sponsor.

Other Identifiers

1K01HL115534

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Mays-1

Identifier Type: -

Identifier Source: org_study_id