Exercise for Women With Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Women; Peripheral Artery Disease; Claudication
• Interventions: Behavioral: Control; Behavioral: Walking Exercise

• 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

Arm && Interventions

Group	Intervention	Description
Control	Control	Light resistance training without any walking
Supervised Exercise	Walking Exercise	Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake	3 months
Change in daily ambulatory activity	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