Exercise for Women With Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Peripheral Artery Disease Claudication Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Supervised 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.

Group Type EXPERIMENTAL

Walking Exercise

Intervention Type BEHAVIORAL

3 times per week for 3 months

Control

Light resistance training without any walking

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Resistance training 3 times per week for 3 months

Interventions

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Walking Exercise

3 times per week for 3 months

Intervention Type BEHAVIORAL

Control

Resistance training 3 times per week for 3 months

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No