Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
muscle strengthening targeted on ischemic areas
global muscle strenghtening
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Adapted Physical Activity
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Du MansRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
APA with consideration of ischemia localization
APA without consideration of ischemia localization
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04800276
First Posted
March 12, 2021
Last Updated
March 8, 2022
Sponsor
Centre Hospitalier le Mans
1. Study Identification
Unique Protocol Identification Number
NCT04800276
Brief Title
Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease
Acronym
ACTIV'AO
Official Title
Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, Adapted Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APA with consideration of ischemia localization
Arm Type
Experimental
Arm Title
APA without consideration of ischemia localization
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
muscle strengthening targeted on ischemic areas
Intervention Description
muscle strengthening targeted on ischemic areas
Intervention Type
Other
Intervention Name(s)
global muscle strenghtening
Intervention Description
global muscle strenghtening
Primary Outcome Measure Information:
Title
Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia
Description
The efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance
Time Frame
12 weeks after inclusion
Secondary Outcome Measure Information:
Title
Assess efficacity of Adapted Physical Activity with localization of ischemia on walking abilities compared to Adapted Physical activity without localization of ischemia
Description
The efficacity of Adapted Physical Activity was assessed by measure of walking speed with actimeter
Time Frame
12 weeks after inclusion
Title
Assess efficacity of Adapted Physical Activity with localization of ischemia on static balance compared to Adapted Physical activity without localization of ischemia
Description
The efficacity of Adapted Physical Activity was assessed by measure of balance static with stabilometry Platform.
Time Frame
12 weeks after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
02 44 71 07 81
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Karine MONTACLAIR
Phone
02 43 43 43 43
Email
kmontaclair@ch-lemans.fr
Facility Information:
Facility Name
Centre Hospitalier Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
02 44 71 07 81
Email
cjadeau@ch-lemans.fr
12. IPD Sharing Statement
Learn more about this trial
Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease
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