Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— ACTIV'AO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800276
• Other study ID #: CHM-2019/S18/09
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 02 44 71 07 81
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• muscle strengthening targeted on ischemic areas
muscle strengthening targeted on ischemic areas
• global muscle strenghtening
global muscle strenghtening

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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