View Clinical Trial (Medical Research Study)
Home-based vs. Supervised Exercise for Claudicants
| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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73117 |
| Conditions: |
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Intermittent Claudication |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00618670 |
| Primary Contact: |
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Principal Investigator
Andrew W Gardner, PhD
University of Oklahoma
Polly Montgomery, MS
Phone: 405-271-6764 ext. 42719
Email: polly-montgomery@ouhsc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Oklahoma City, Oklahoma 73117
United States
Andrew W Gardner, PhD
Phone: 405-271-4272
Email: andrew-gardner@ouhsc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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