Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Phys… (NCT06493955) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)
France308 participantsStarted 2026-09
Plain-language summary
Type 2 diabetes is on the increase worldwide. Two major risk factors have been identified: overweight and physical inactivity. National and international recommendations encourage general practitioner to guide patients in changing their lifestyle. As regards physical activity in France, general practitioner have been able to prescribe adapted physical activity (APA) for their patients since 2016. In type 2 diabetes, it is known that physical activity interventions are cost-effective. However, these interventions are often too expensive and far removed from real life. It is also known that the benefits of intervention increase up to 18 months, then diminish to zero at 36 months. In Nouvelle-Aquitaine, France, the "PEPS Sport-santé network", offers physical activity coaching for patients who are not sufficiently active: the "Passerelle" program. Patients can benefit from a weekly physical activity session for 6 months.
The investigators would therefore like to assess whether extending the existing "Passerelle program" by 6 months, with one session every 15 days, is effective in maintaining the volume of physical activity 12 months after the end of the intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with type 2 diabetes with initial diagnosis of fasting blood glucose \> 1.26 g/l on 2 occasions
* Patient aged 18 or over
* Patient with a Marshall score ≤ 3
* Patient residing in the Nouvelle-Aquitaine region
* Patient eligible for the "Passerelle" program
* Patient willing to participate
* Patient agreeing to take part in the study and having signed an informed consent form
* Person affiliated or benefiting from a social security scheme.
Exclusion Criteria:
* Patient with any other unstabilized pathology:
* Cardiovascular: unstable angina, stress angina, malignant hypertension, recent myocardial infarction, unstabilized heart disease
* Pulmonary: uncontrolled asthma, COPD exacerbation
* Endocrine: diabetes with HbA1c \> 9%, plantar perforator disease
* Pregnant patient
* Diabetic patient with contraindication to APA prescription
* Patient under court protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ONAPS-PAQ questionnaire,
Timeframe: 12 months after the end of the intervention