Exercise for Elderly Peripheral Revascularized Patients

Study Overview
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Brief Summary
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The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.

Detailed Description
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Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function. This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.

Official Title
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Exercise for Elderly Peripheral Revascularized Patients

Conditions
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Peripheral Artery Disease, Intermittent Claudication

Intervention / Treatment
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* Behavioral: Treadmill exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lower extremity arterial bypass at least 3 months prior to screening infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening Exclusion Criteria: persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD), persistent tissue loss due to PAOD (Fontaine Stage IV for PAD), medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.) cognitive dysfunction (mini-mental state examination score of less than 24)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

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: 1<br> | Behavioral: Treadmill exercise<br>* Graded treadmill walking 3 times per week for 3 months<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder