Adapted Physical Activity in the Treatment of Anorexia:

NCT05477537 | Recruiting DMC

• 1 other identifier: 2022-A00416-37
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

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.

Conditions

Anorexia Nervosa

Keywords

Adapted physical activity

Outcome Measures

Primary Outcomes (1)

• Body Mass Index change

  Difference between the two groups (treatment as usual versus the add on group:ie: treatment as usual plus adapted physical activity) concerning the of change of body Mass Index (Weight/(height)² between baseline and the end of the adapted physical activity program (ie: at 8 weeks after baseline). Weight will be measured with the subject wearing only underwear on the same calibrated scales. Stature will be measured using a stadiometer.

  Inclusion (start of research) and 9 week later (=T3)

Secondary Outcomes (9)

• Physical self Change

  First program session (T1= one week after inclusion) / 8 week later T1 (end of program = T2) / 6 month after T2 (=T4)

• Physical activity currently change

  First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) /6 month after T2 (=T4)

• Physical activity currently change

  First program session (T1= one week after inclusion) /8 week later T1 (end of program=T2) /6 month after T2 (=T4)

• Physical activity currently change

  First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)

• Perception of the body shape change

  First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)

Study Arms (2)

Add-on group

EXPERIMENTAL

Subjects with Anorexia Nervosa (AN) involved in a day hospital or an inpatient program following HAS guidelines for anorexia nervosa treatment (treatment as usual) who will receive in addition an adapted physical activity program (one lesson per week, during 8 weeks)

Other: Adapted physical activity program

Treatment as usual group

ACTIVE COMPARATOR

Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual).

Other: Treatment as usual group

Interventions

Adapted physical activity program OTHER

subjects with Anorexia Nervosa (AN) involved in a day hospital or an inpatient program following HAS guidelines for anorexia nervosa treatment (treatment as usual) who will receive in addition an adapted physical activity program (one lesson per week, during 8 weeks) Adapted Physical Activity program, including psychoeducation on both problematic physical activity and consequences in terms of physical activity good practice leads to a better outcome among persons suffering from anorexia nervosa.

Also known as: APA

Add-on group

Treatment as usual group OTHER

Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)

Treatment as usual group

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,
• Refusal to participate.

Sponsors & Collaborators

• Fondation Santé des Étudiants de France: lead

Study Sites (7)

CHU Lille

Lille, 59000, France

WITHDRAWN

Clinique Saint Vincent de Paul

Lyon, 69000, France

RECRUITING

CHU Montpellier

Montpellier, 34000, France

RECRUITING

CHU Nantes - service d'addictologie et Psychiatrie de Liaison

Nantes, 44000, France

RECRUITING

GHU Saine Anne

Paris, 75014, France

RECRUITING

UDJ Michel Ange

Paris, 75016, France

RECRUITING

CHU St Etienne

Saint-Etienne, 42000, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Nathalie Godart, PU-PH

  Fondation Santé des Étudiants de France

  STUDY DIRECTOR

Central Study Contacts

Nathalie Godart, PU-PH

CONTACT

01.45.89.43.39; nathalie.godart@fsef.net

Laurence Kern, MCU

CONTACT

laurence.kern@gmail.com

Study Design

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

Model Details: This protocol is to carry out an open, multi-centric, randomized controlled trial assessing a population of adolescents suffering from Anorexia Nervosa according to the DSM-5 criteria. Randomisation will be centralised and stratified according to the status of treatment at inclusion (ambulatory care or day hospitalisation - the latter possibly entailing a selection bias for reason of severity), and the centre. A randomisation list will be generated on computer with blocks of variable size by a statistician independent from the group recruiting or taking care of patients at INSERM CESP, it will be include in the e-CRF procedure.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 28, 2022
• Study Start: November 14, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)