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

• Sponsor: Centre Hospitalier le Mans (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04800276
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Other: muscle strengthening targeted on ischemic areas; Other: global muscle strenghtening	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two parallel armsTwo parallel arms
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: APA with consideration of ischemia localization	Other: muscle strengthening targeted on ischemic areas; muscle strengthening targeted on ischemic areas
Experimental: APA without consideration of ischemia localization	Other: global muscle strenghtening; global muscle strenghtening

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Du Mans	Le Mans		France	72000

Sponsors and Collaborators

• Centre Hospitalier le Mans

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier le Mans
• ClinicalTrials.gov Identifier: NCT04800276
• Other Study ID Numbers: CHM-2019/S18/09
• First Posted: Mar 16, 2021
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier le Mans: Peripheral Arterial Disease, Adapted Physical Activity
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of Mar 9, 2022