Exercise for Women With Peripheral Arterial Disease

University of Oklahoma1 site in 1 country33 target enrollmentJuly 2009

ConditionsPeripheral Artery Disease Claudication Women

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: University of Oklahoma
Enrollment: 33
Locations: 1
Primary Endpoint: Change in 6-minute walk distance
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 attention-control group.

Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

February 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Oklahoma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 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.)
•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