NCT05477537 Adapted Physical Activity in the Treatment of Anorexia:
| NCT ID | NCT05477537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Santé des Étudiants de France |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2023-11-14 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
People with anorexia nervosa are known to engage in significant physical activity or sports. This practice is problematic because of the state of malnutrition, its interference with re-nutrition and the somatic and nutritional complications that the effect of physical activity can cause in these people. This significant physical activity is also called hyperactivity in the literature, it is in fact a problematic use of physical activity, it is a symptom commonly observed in people suffering from anorexia nervosa (in 31 to 80% cases). In this context, Ms. Kern lecturer in Sciences and Techniques of Physical and Sports Activities (STAPS) at the University of Paris Nanterre has developed in collaboration with the clinical team (Pre Godart) an adapted physical activity program (APA) , for patients suffering from anorexia nervosa. The APA program includes 8 sessions of 1h30 including an important part of psychoeducation. The effectiveness of this program will be evaluated in terms of both restoration of body mass index and improvement in overall health. The project's hypothesis is that adding a standardized 8-week Adapted Physical Activity program to the usual care, including psychoeducation on both problematic physical activity and the consequences in terms of good practice of physical activity leads to a better outcome of overall care in people with anorexia nervosa.
Eligibility Criteria
Inclusion Criteria: * Anorexia nervosa patients (DSM 5 criteria), * over or equal to 12 years old, * Treated in the specialised eating disorder centres involved in the study either in the day hospital program or in the inpatient program, * Understanding, reading and writing French, * Benefiting from social cover * Have read the information notice and have consented to participate in the study by signing a written consent Exclusion Criteria: * Somatic instability needing intensive medical care or monitoring (intensity is adapted in each session to each patient) or psychiatric emergency (suicidal risk and/or acute psychiatric symptomatology), * Somatic complication forbidding any physical activity, * Absence social cover, * Patients in an emergency situation, incapable of giving their consent or adults under guardianship or curatorship, * Pregnant or breastfeeding women (declarative: question asked to the patient during inclusion), * Refusal to participate.
Contact & Investigator
Nathalie Godart, PU-PH
STUDY DIRECTOR
Fondation Santé des Étudiants de France
Frequently Asked Questions
Who can join the NCT05477537 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 40 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05477537 currently recruiting?
Yes, NCT05477537 is actively recruiting participants. Contact the research team at nathalie.godart@fsef.net for enrollment information.
Where is the NCT05477537 trial being conducted?
This trial is being conducted at Lille, France, Lyon, France, Montpellier, France, Nantes, France and 3 additional locations.
Who is sponsoring the NCT05477537 clinical trial?
NCT05477537 is sponsored by Fondation Santé des Étudiants de France. The principal investigator is Nathalie Godart, PU-PH at Fondation Santé des Étudiants de France. The trial plans to enroll 220 participants.