Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)

NCT06493955 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/47
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Adapted Physical Activity; general practice

Outcome Measures

Primary Outcomes (1)

• ONAPS-PAQ questionnaire,

  Measurement of weekly physical activity volume using the " national observatory on physical activity and sedentariness - physical activity questionnaire" (ONAPS-PAQ), score given in minutes per week : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases

  12 months after the end of the intervention

Secondary Outcomes (7)

• Physical activity

  Month 0 (inclusion) and Month 6, Month 12, Month 18, Month 24 after inclusion

• Sedentariness

  At inclusion and 6 months after inclusion and 12 months after the end of the intervention.

• Weight change

  At inclusion and 6 months after inclusion and 12 months after the end of the intervention.

• Walk test

  At inclusion and 6 months after inclusion and 12 months after the end of the intervention.

• Therapeutic escalation

  12 months after the end of the intervention.

Study Arms (2)

experimental arm

EXPERIMENTAL

Patients with type 2 diabetes included in the adapted physical activity arm for 12 months

Other: Adapted physical activity for 12 months

control arm

ACTIVE COMPARATOR

Type 2 diabetes patients with standard prescription for adapted physical activity (6 months)

Other: Adapted physical activity for 6 months

Interventions

Adapted physical activity for 12 months OTHER

6 additional months of adapted physical activity after the 6 first months

experimental arm

Adapted physical activity for 6 months OTHER

standard 6-month prescription for adapted physical activity

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Cabinet Médical Bergerac

Bergerac, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

CUGERONE Arnaud, Dr

CONTACT

arnaud.cugerone@u-bordeaux.fr

Fabienne SAUVETRE

CONTACT

05 57 82 14 87; fabienne.sauvetre@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparative, multicenter, interventional, superiority study, randomized in two unblinded parallel groups. Randomization will be 1:1.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

FR (1)