Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

NCT04800276 | Unknown

• 1 other identifier: CHM-2019/S18/09
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Adapted Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

APA with consideration of ischemia localization

EXPERIMENTAL

Other: muscle strengthening targeted on ischemic areas

APA without consideration of ischemia localization

EXPERIMENTAL

Other: global muscle strenghtening

Interventions

muscle strengthening targeted on ischemic areas OTHER

muscle strengthening targeted on ischemic areas

APA with consideration of ischemia localization

global muscle strenghtening OTHER

global muscle strenghtening

APA without consideration of ischemia localization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Christelle JADEAU

CONTACT

02 44 71 07 81; cjadeau@ch-lemans.fr

Karine MONTACLAIR

CONTACT

02 43 43 43 43; kmontaclair@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arms

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

FR (1)