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RecruitingNCT04800276ACTIV'AOUpdated Jul 1, 2026

Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

An interventional study of muscle strengthening targeted on ischemic areas and global muscle strenghtening in Peripheral Arterial Disease, sponsored by Centre Hospitalier le Mans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral Arterial Disease
  • Adapted Physical Activity
  • maximum walking distance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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
  • Socially insured patients over 18 ;
  • Patient who has signed the consent form.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    APA with consideration of ischemia localization

    Other: muscle strengthening targeted on ischemic areas

  • Experimental
    APA without consideration of ischemia localization

    Other: global muscle strenghtening

Interventions

  • Othermuscle strengthening targeted on ischemic areas

    muscle strengthening targeted on ischemic areas

  • Otherglobal muscle strenghtening

    global muscle strenghtening

05

What researchers measure

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

    Time frame: 12 weeks after inclusion

Secondary outcomes

  1. 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

    Time frame: 12 weeks after inclusion

  2. 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.

    Time frame: 12 weeks after inclusion

  3. Assess quality of Life

    Assess quality of life with the "Vascular Quality of Life" questionnaire, and physical activity levels with the "Global Physical Activity Questionnaire".

    Time frame: At week 12

  4. Assess strength capacities

    The efficacy of Adapted Physical Activity on strength capacities is measured using grip strength, dynamometers and the chair lift test

    Time frame: 12 weeks after inclusion

  5. Assess neuromuscular activity

    The efficacy of Adapted Physical Activity on neuromuscular activity is measured using surface electromyography

    Time frame: 12 weeks after inclusion

06

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Du Mans
    Le Mans, 72000, France
    • Christelle JADEAU · Contact · cjadeau@ch-lemans.fr · 02 44 71 07 81
    • Claire NEVEUX-BRECHETEAU, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT04800276
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Mar 16, 2021
Start date
Feb 11, 2021
Primary completion
Nov 11, 2026 (estimated)
Completion
Nov 11, 2026 (estimated)
Last update
Jul 1, 2026

Study contacts

Christelle JADEAU
Contact
cjadeau@ch-lemans.fr
02 44 71 07 81
Karine MONTACLAIR
Contact
kmontaclair@ch-lemans.fr
02 43 43 43 43

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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