Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

Study Overview
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Brief Summary
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The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes. The location of the pain (calves and/or thighs and/or buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied. These limitations are very disabling and impact the quality of life of patients. In addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease. Our main hypothesis is that the physical activity rehabilitation protocol Activ'AO will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a standard APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.

Official Title
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Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: muscle strengthening targeted on ischemic areas
* Other: global muscle strenghtening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Lower Limb Peripheral Arterial Disease with IPSC < 0.90, arterial stenosis in the lower limbs and intermittent claudication No contraindication to physical activity Exclusion Criteria: Severe or unstable cardiopulmonary pathologies, contraindicating exercise training Unstable angina or myocardial infarction <3 months Severe rheumatological pathology of the lower limbs Amputee of a lower or upper limb fitted with a device Extensive dermatosis of the lower limbs Known NYHA grade III or IV heart failure Known severe respiratory pathology Parkinson's disease, hemiplegia or paraplegia

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Two parallel arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APA with consideration of ischemia localization<br> | Other: muscle strengthening targeted on ischemic areas<br>* muscle strengthening targeted on ischemic areas<br>|
| Experimental: APA without consideration of ischemia localization<br> | Other: global muscle strenghtening<br>* global muscle strenghtening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia | The efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance | 12 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacity of Adapted Physical Activity with localization of ischemia on walking abilities compared to Adapted Physical activity without localization of ischemia | The efficacity of Adapted Physical Activity was assessed by measure of walking speed with actimeter | 12 weeks after inclusion | 
| Assess efficacity of Adapted Physical Activity with localization of ischemia on static balance compared to Adapted Physical activity without localization of ischemia | The efficacity of Adapted Physical Activity was assessed by measure of balance static with stabilometry Platform. | 12 weeks after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Adapted Physical Activity