Exercise Rehabilitation of Younger and Older People With Claudication

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.

Detailed Description
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Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

Official Title
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Exercise Rehabilitation of Younger and Older People With Claudication

Conditions
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Intermittent Claudication

Intervention / Treatment
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* Behavioral: Walking Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of intermittent claudication Exercise tolerance limited by intermittent claudication during a screening treadmill test Ankle/brachial index (ABI) at rest less than 0.90 Live independently at home Exclusion Criteria: Absence of PAD (peripheral artery disease) Asymptomatic PAD (Fontaine stage I) Rest pain PAD (Fontaine stage III) Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure) Active cancer, renal disease, or liver disease Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication

Ages Eligible for Study
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Minimum Age: 45 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>Low intensity group (40% of maximal exercise capacity) | Behavioral: Walking Exercise<br>* Intermittent treadmill walking to near maximal claudication pain three days per week<br>|
| Experimental: 2<br>High intensity group (80% of maximal exercise capacity) | Behavioral: Walking Exercise<br>* Intermittent treadmill walking to near maximal claudication pain three days per week<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. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life. |  | 6 months | 

 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