Cardiovascular Diseases Clinical Trial
Official title:
Improving Functioning in Peripheral Arterial Disease
Verified date | July 2012 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | March 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 150 peripheral arterial disease patients with and without IC Exclusion Criteria: - 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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six-minute walk distance | Measured at baseline and follow-up study visits | No | |
Primary | Summary performance score | Measured at baseline and follow-up study visits | No |
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