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Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04800276
Acronym
ACTIV'AO
Enrollment
70
Registered
2021-03-16
Start date
2021-02-11
Completion date
2026-11-11
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Adapted Physical Activity, maximum walking distance

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.

Interventions

OTHERmuscle strengthening targeted on ischemic areas

muscle strengthening targeted on ischemic areas

OTHERglobal muscle strenghtening

global muscle strenghtening

Sponsors

Centre Hospitalier le Mans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two parallel arms

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * Socially insured patients over 18 ; * Patient who has signed the consent form.

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 * Adults subject to enhanced protection, deprived of their liberty by judicial or administrative decision * Persons unable to consent * Be in a period of exclusion from other interventional research. * Any event (injury, surgery, etc.) occurring during the protocol period that could have an impact on results.

Design outcomes

Primary

MeasureTime frameDescription
Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia12 weeks after inclusionThe efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance

Secondary

MeasureTime frameDescription
Assess efficacity of Adapted Physical Activity with localization of ischemia on walking abilities compared to Adapted Physical activity without localization of ischemia12 weeks after inclusionThe 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 ischemia12 weeks after inclusionThe efficacity of Adapted Physical Activity was assessed by measure of balance static with stabilometry Platform.
Assess quality of LifeAt week 12Assess quality of life with the "Vascular Quality of Life" questionnaire, and physical activity levels with the "Global Physical Activity Questionnaire".
Assess strength capacities12 weeks after inclusionThe efficacy of Adapted Physical Activity on strength capacities is measured using grip strength, dynamometers and the chair lift test
Assess neuromuscular activity12 weeks after inclusionThe efficacy of Adapted Physical Activity on neuromuscular activity is measured using surface electromyography

Countries

France

Contacts

CONTACTChristelle JADEAU
cjadeau@ch-lemans.fr02 44 71 07 81
CONTACTKarine MONTACLAIR
kmontaclair@ch-lemans.fr02 43 43 43 43

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026