Exercise for Women With Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

Official Title
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Exercise for Women With Peripheral Arterial Disease

Conditions
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Peripheral Artery Disease, Claudication, Women

Intervention / Treatment
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* Behavioral: Walking Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Exercise<br>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. | Behavioral: Walking Exercise<br>* 3 times per week for 3 months<br>|
| Active Comparator: Control<br>Light resistance training without any walking | Behavioral: Control<br>* Resistance training 3 times per week for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calf muscle oxygen saturation |  | 3 months | 
| Change in daily ambulatory activity |  | 3 months | 
| Change in walking economy |  | 3 months | 
| Change in peak oxygen uptake |  | 3 months |