Oklahoma City, Oklahoma 73117


Purpose:

The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.


Study summary:

This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function. We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program. The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.


Criteria:

Inclusion Criteria: - Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire - Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol - Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test Exclusion Criteria: - Absence of PAD (peripheral artery disease) - Asymptomatic PAD (Fontaine stage I) - Rest pain due to PAD (Fontaine stage III) - Tissue loss due to PAD (Fontaine stage IV) - Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.) - Cognitive dysfunction (mini-mental state examination score less than 24)


NCT ID:

NCT00618670


Primary Contact:

Principal Investigator
Andrew W Gardner, PhD
University of Oklahoma

Polly Montgomery, MS
Phone: 405-271-6764 ext. 42719
Email: polly-montgomery@ouhsc.edu


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73117
United States

Andrew W Gardner, PhD
Phone: 405-271-4272
Email: andrew-gardner@ouhsc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 18, 2018

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