Status:
COMPLETED
Exercise for Women With Peripheral Arterial Disease
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Oklahoma Center for the Advancement of Science and Technology
Milton S. Hershey Medical Center
Conditions:
Peripheral Artery Disease
Claudication
Eligibility:
FEMALE
60-100 years
Phase:
NA
Brief Summary
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attent...
Eligibility Criteria
Inclusion
- women 60 years of age and older having a 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
- an ankle/brachial index (ABI) \< 0.90 at rest or \< 0.73 immediately following the treadmill exercise test
- at least one year past menopause
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.)
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
- cognitive dysfunction (mini-mental state examination score \< 24)
- active cancer, renal disease, or liver disease
- a calf skin fold measurement \> 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
- pulse arterial oxygen saturation of the index finger \< 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01241747
Start Date
July 1 2009
End Date
February 1 2016
Last Update
March 1 2019
Active Locations (1)
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1
Clinical Research Center, Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033