Home-based vs. Supervised Exercise for People With Claudication

University of Oklahoma135 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

135

Conditions

Intermittent Claudication

Interventions

Walking ExerciseBEHAVIORAL

Three times per week for 3 months

Control--Resistance TrainingBEHAVIORAL

Three times per week for 3 months

Eligibility

Sex: ALLMin age: 35 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

General Clinical Research Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Time frame: 3 months

Secondary Outcomes

Change in walking efficiency

Time frame: 3 months

Change in calf muscle circulation and calf muscle oxygen

Time frame: 3 months

Change in health-related quality of life

Time frame: 3 months

Data from ClinicalTrials.gov

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