Community Walking Exercise for Patients With Peripheral Artery Disease

NCT02075502 | Completed

• 2 other identifiers: Mays-11K01HL115534
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Artery Disease

Keywords

claudication; community walking exercise; community-based participatory research; exercise adherence; endovascular therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (6)

Exercise therapy

EXPERIMENTAL

Claudication, no peripheral revasc

Behavioral: Exercise therapy

Exercise advice

PLACEBO COMPARATOR

Claudication, no peripheral revasc

Behavioral: Exercise therapy

lower extremity ET, exercise therapy

EXPERIMENTAL

Behavioral: Exercise therapy; Procedure: lower extremity ET

lower extremity ET, exercise advice

PLACEBO COMPARATOR

Procedure: lower extremity ET

Peripheral open intervention, exercise therapy

EXPERIMENTAL

Behavioral: Exercise therapy; Procedure: peripheral open intervention

Peripheral open intervention, exercise advice

PLACEBO COMPARATOR

Procedure: peripheral open intervention

Interventions

Exercise therapy 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; Exercise therapy; Peripheral open intervention, exercise therapy; lower extremity ET, exercise therapy

lower extremity ET PROCEDURE

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

lower extremity ET, exercise advice; lower extremity ET, exercise therapy

peripheral open intervention PROCEDURE

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

Peripheral open intervention, exercise advice; Peripheral open intervention, exercise therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

International Heart Institute of Montana Foundation

Missoula, Montana, 59802, United States

Location

Related Links

• Click here for more information about the sponsor.
• Click here for more information about the sponsor.

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ryan J. Mays, PhD, MPH, MS

  International Heart Institute of Montana Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

US (1)