CompletedNot Applicable

Home-based vs. Supervised Exercise for People With Claudication

United States135 participantsStarted 2006-09

Plain-language 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 ambulatory function.

Who can participate

Age range35 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Timeframe: 3 months

Trial details

NCT IDNCT00618670

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Intermittent Claudication trials