Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04800276

Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location status: Recruiting

Location contact

Christelle JADEAU

CONTACT

[email protected]

02 44 71 07 81

Claire NEVEUX-BRECHETEAU, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

muscle strengthening targeted on ischemic areas

Other

muscle strengthening targeted on ischemic areas

global muscle strenghtening

Other

global muscle strenghtening

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

    Time frame: 12 weeks after inclusion

    The efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance

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

    Time frame: 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

    Time frame: 12 weeks after inclusion

    The efficacity of Adapted Physical Activity was assessed by measure of balance static with stabilometry Platform.

  3. Assess quality of Life

    Time frame: At week 12

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

  4. Assess strength capacities

    Time frame: 12 weeks after inclusion

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

  5. Assess neuromuscular activity

    Time frame: 12 weeks after inclusion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

02 44 71 07 81

Karine MONTACLAIR

CONTACT

[email protected]

02 43 43 43 43

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Official study title

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

Acronym: ACTIV'AO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.