Status:
COMPLETED
Home-based vs. Supervised Exercise for People With Claudication
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Oklahoma Center for the Advancement of Science and Technology
National Institute on Aging (NIA)
Conditions:
Intermittent Claudication
Eligibility:
All Genders
35-100 years
Phase:
NA
Brief Summary
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 ...
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 exercis...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00618670
Start Date
September 1 2006
End Date
September 1 2016
Last Update
April 2 2018
Active Locations (1)
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1
General Clinical Research Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117