Home-based vs. Supervised Exercise for People With Claudication

University of Oklahoma (OU)

Status: Completed

Conditions: Intermittent Claudication

Treatments: Behavioral: Walking Exercise; Behavioral: Control--Resistance Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00618670

R01AG024296 (U.S. NIH Grant/Contract)

AG0095

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 135 patients

Sex: All

Ages: 35 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

1

Experimental group

Description:

Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group

Treatment:

Behavioral: Walking Exercise

2

Experimental group

Description:

Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity

Treatment:

Behavioral: Walking Exercise

3

Active Comparator group

Description:

Light resistance training without any walking exercise

Treatment:

Behavioral: Control--Resistance Training