Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Other: global muscle strenghtening; Other: muscle strengthening targeted on ischemic areas

• Registration Number: NCT04800276
• Lead Sponsor: Centre Hospitalier le Mans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APA without consideration of ischemia localization	global muscle strenghtening	-
APA with consideration of ischemia localization	muscle strengthening targeted on ischemic areas	-

Primary Outcome Measures

Name	Time	Method
Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia	12 weeks after inclusion	The efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Du Mans; 🇫🇷 Le Mans, France