Exercise for Women With Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Women; Peripheral Artery Disease; Claudication

• Registration Number: NCT01241747
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain	3 months
Change in 6-minute walk distance	3 months

Secondary Outcome Measures

Name	Time	Method
Change in daily ambulatory activity	3 months
Change in peak oxygen uptake	3 months
Change in calf muscle oxygen saturation	3 months
Change in walking economy	3 months

Trial Locations

Locations (1)

Clinical Research Center, Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States