Home-Based vs. Supervised Exercise for Claudicants (2)

Principal Investigator: Andrew W. Gardner, PhD

Abstract:

Ambulatory dysfunction secondary to intermittent claudication is the initial step in a downward spiral of physical function in older patients with PAD.  The overall hypothesis of this project is that a home-based exercise program utilizing new physical activity monitoring technology that quantifies the volume and intensity of walking will be as equally efficacious as a standard hospital-based supervised exercise program and better than usual care control in improving ambulation, physical function, vascular function, and health-related quality of life through the physiologic mechanisms of improved walking economy, calf muscle circulation, and calf muscle oxygenation.  This hypothesis will be tested in a prospective, randomized controlled clinical trial that compares a home-based exercise group, a hospital-based exercise group, and a delayed-entry, non-exercise control group to address the following three specific aims:

Specific Aims:

Specific Aim 1: To determine the efficacy of a home-based exercise rehabilitation program to elicit improvements in outcome measures pertaining to ambulation, physical function, vascular function, and health-related quality of life.

Specific Aim #2.  To compare the changes in these outcome measures in patients randomized into either a home-based exercise program, a standard hospital-based supervised exercise program, or and non-exercise usual care control group.

Specific Aim #3.  To determine whether alterations in walking economy, calf muscle circulation, and calf muscle oxygenation are the primary mechanisms by which home-based and hospital-based exercise rehabilitation improve ambulation and physical function.

Participant Inclusion Criteria:

All patients will be classified as having intermittent claudication due to PAD (Fontaine Stage II)28 defined by the following inclusion criteria:

1. a positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
2. exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
3. an ankle/brachial index (ABI) < 0.90 at rest, which decreases to < 0.73 immediately following the treadmill exercise test
4. age > 50 years.

The exclusion criteria will consist of the following:

1. absence of PAD
2. asymptomatic PAD (Fontaine stage I)
3. rest pain due to PAD (Fontaine stage III)
4. tissue loss due to PAD (Fontaine stage IV)
5. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine31 (e.g., acute myocardial infarction, unstable angina, etc.)
6. cognitive dysfunction (mini-mental state examination score < 24).

Participant Compensation:

Contact Information:

Kristy Scott, Exercise Physiologist, (405) 271-4272 x 42742