Home-based vs. Supervised Exercise for People With Claudication

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.

Detailed Description
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This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function. We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program. The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.

Official Title
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Home-based vs. Supervised Exercise for Claudicants

Conditions
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Intermittent Claudication

Intervention / Treatment
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* Behavioral: Walking Exercise
* Behavioral: Control--Resistance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test 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.) Cognitive dysfunction (mini-mental state examination score less than 24)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 100 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>Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group | Behavioral: Walking Exercise<br>* Three times per week for 3 months<br>|
| Experimental: 2<br>Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity | Behavioral: Walking Exercise<br>* Three times per week for 3 months<br>|
| Active Comparator: 3<br>Light resistance training without any walking exercise | Behavioral: Control--Resistance Training<br>* Three 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 the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking efficiency |  | 3 months | 
| Change in calf muscle circulation and calf muscle oxygen |  | 3 months | 
| Change in health-related quality of life |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder, muscle function, muscle strength, quality of life