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

C

Centre Hospitalier le Mans

Status

Unknown

Conditions

Peripheral Arterial Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04800276
CHM-2019/S18/09

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

APA with consideration of ischemia localization
Experimental group
Treatment:
Other: muscle strengthening targeted on ischemic areas
APA without consideration of ischemia localization
Experimental group
Treatment:
Other: global muscle strenghtening

Trial contacts and locations

1

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Central trial contact

Karine MONTACLAIR; Christelle JADEAU

Data sourced from clinicaltrials.gov

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