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
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: muscle strengthening targeted on ischemic areas
Other: global muscle strenghtening
muscle strengthening targeted on ischemic areas
global muscle strenghtening
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
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
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
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
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
Assess neuromuscular activity
The efficacy of Adapted Physical Activity on neuromuscular activity is measured using surface electromyography
Time frame: 12 weeks after inclusion
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Centre Hospitalier le Mans