Peripheral Arterial DiseaseACTIV'AONCT04800276
Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease
A study testing muscle strengthening targeted on ischemic areas and global muscle strenghtening in people with Peripheral Arterial Disease, run by Centre Hospitalier le Mans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- muscle strengthening targeted on ischemic areas and global muscle strenghtening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2021to 11 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, 02 44 71 07 81, cjadeau@ch-lemans.fr
Claire NEVEUX-BRECHETEAU, MD
About this study
Official title: Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
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.
Read more
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- muscle strengthening targeted on ischemic areas, global muscle strenghtening
- Keywords
- Peripheral Arterial Disease, Adapted Physical Activity, maximum walking distance
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle strengthening targeted on ischemic areasOther
muscle strengthening targeted on ischemic areas
global muscle strenghteningOther
global muscle strenghtening
| Study group | Role | What they receive |
|---|---|---|
| APA with consideration of ischemia localization | Experimental | Not described Receives: Other: muscle strengthening targeted on ischemic areas |
| APA without consideration of ischemia localization | Experimental | Not described Receives: Other: global muscle strenghtening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks after inclusion
Secondary outcomes (5)
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
Measured: 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.
Measured: 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".
Measured: 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
Measured: 12 weeks after inclusion
Assess neuromuscular activity
The efficacy of Adapted Physical Activity on neuromuscular activity is measured using surface electromyography
Measured: 12 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start11 Feb 2021
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800276
- Sponsor's protocol ID
- CHM-2019/S18/09
- Acronym
- ACTIV'AO
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
- ClinicalTrials.gov ID
- NCT04800276
- Acronym / sponsor ID
- ACTIV'AO / CHM-2019/S18/09
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Adapted Physical Activity, maximum walking distance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel arms
| Arm | Type | Receives |
|---|---|---|
| APA with consideration of ischemia localization | Experimental | Other: muscle strengthening targeted on ischemic areas |
| APA without consideration of ischemia localization | Experimental | Other: global muscle strenghtening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle strengthening targeted on ischemic areasmuscle strengthening targeted on ischemic areas | Other | APA with consideration of ischemia localization |
| global muscle strenghteningglobal muscle strenghtening | Other | APA without consideration of ischemia localization |
Primary outcome
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
5 secondary outcomes
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
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
Assess quality of Life
Time frame: At week 12
Assess strength capacities
Time frame: 12 weeks after inclusion
Assess neuromuscular activity
Time frame: 12 weeks after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle strengthening targeted on ischemic areas and global muscle strenghtening in people with Peripheral Arterial Disease, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (02 44 71 07 81, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.