Adapted Physical Activity in Patients With Lower Limb 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-01

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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APA with consideration of ischemia localization

Group Type EXPERIMENTAL

muscle strengthening targeted on ischemic areas

Intervention Type OTHER

muscle strengthening targeted on ischemic areas

APA without consideration of ischemia localization

Group Type EXPERIMENTAL

global muscle strenghtening

Intervention Type OTHER

global muscle strenghtening

Interventions

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muscle strengthening targeted on ischemic areas

Intervention Type OTHER

global muscle strenghtening

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No