Status:
COMPLETED
Improving Functioning in Peripheral Arterial Disease
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Peripheral Vascular Diseases
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.
Detailed Description
BACKGROUND: Previous work demonstrates that functional limitations associated with peripheral arterial disease (PAD) are diverse and include slower walking speed, poorer walking endurance, and impair...
Eligibility Criteria
Inclusion
- 150 peripheral arterial disease patients with and without IC
Exclusion
- Below or above-knee amputation
- Wheelchair confinement
- Inability to walk on a treadmill or inability to perform progressive resistance training
- Inability to return to the medical center three times weekly for 6 months
- Walking impairment due to a cause other than PAD
- Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
- Planned lower extremity revascularization or any other major surgery within 12 months
- Any increase in anginal symptoms during the previous 6 months or angina at rest
- Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
- Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
- Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
- Myocardial infarction or coronary artery bypass grafting during the previous 3 months
- Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
- Current foot ulcer
- ABI greater than 0.95
- Life expectancy less than 12 months
- Does not speak English
- Patient is currently involved in another clinical trial
- Dementia
- Poorly controlled blood pressure
- Current significant exercise, defined as exercising three times weekly for 30 minutes with sufficient exertion to produce a sweat or other exercise that is comparable to the exercise interventions offered in our protocol
- Treatment for cancer (other than non-melanoma skin cancer) during the past 12 months (including radiation therapy, chemotherapy, or surgery)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00106327
Start Date
September 1 2003
End Date
March 1 2009
Last Update
July 25 2012
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611-3008