Home-based vs. Supervised Exercise for People With Claudication
Recruitment status was Recruiting
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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.
| Condition | Intervention |
|---|---|
|
Intermittent Claudication |
Behavioral: Walking Exercise Behavioral: Control--Resistance Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Home-based vs. Supervised Exercise for Claudicants |
- Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change in walking efficiency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change in calf muscle circulation and calf muscle oxygen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Change in health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 111 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Behavioral: Walking Exercise
Three times per week for 3 months
|
|
Experimental: 2
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
|
Behavioral: Walking Exercise
Three times per week for 3 months
|
|
Active Comparator: 3
Light resistance training without any walking exercise
|
Behavioral: Control--Resistance Training
Three times per week for 3 months
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Polly Montgomery, MS | 405-271-6764 ext 42719 | polly-montgomery@ouhsc.edu |
| United States, Oklahoma | |
| General Clinical Research Center, University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73117 | |
| Contact: Andrew W Gardner, PhD 405-271-4272 ext 42743 andrew-gardner@ouhsc.edu | |
| Contact: Polly S Montgomery, MS 405-271-4272 polly-montgomery@ouhsc.edu | |
| Principal Investigator: Andrew W Gardner, PhD | |
| Sub-Investigator: Steven M Blevins, MD | |
| Principal Investigator: | Andrew W Gardner, PhD | University of Oklahoma |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrew W. Gardner, PhD, University of Oklahoma Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00618670 History of Changes |
| Other Study ID Numbers: | AG0095, R01-AG-24296 |
| Study First Received: | February 15, 2008 |
| Last Updated: | December 18, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
aging gait musculoskeletal disorder therapy peripheral blood vessel disorder |
muscle function muscle strength quality of life |
Additional relevant MeSH terms:
|
Intermittent Claudication Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013