Anorexia NervosaEfAPANCT05477537
Adapted Physical Activity in the Treatment of Anorexia:
A study testing Adapted physical activity program and Treatment as usual group in people with Anorexia Nervosa, run by Fondation Santé des Étudiants de France at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Adapted physical activity program and Treatment as usual group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 7 sitesFrance
- Study dates
- 14 Nov 2023to Apr 2027
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laurence Kern, MCU contact
7 sites in 1 country
France7 sites, 6 recruiting
- Withdrawn
CHU Lille
Lille, 59000
- Recruiting
Clinique Saint Vincent de Paul
Lyon, 69000
Louis Carrier, louis.carrier@csvp.com
- Recruiting
CHU Montpellier
Montpellier, 34000
Sébastien Guillaume, Dr, s-guillaume@chu-montpellier.fr
- Recruiting
CHU Nantes - service d'addictologie et Psychiatrie de Liaison
Nantes, 44000
Marie Grall, PU-PH, marie.bronnec@chu-nantes.fr
- Recruiting
GHU Saine Anne
Paris, 75014
Philip Gorwood, PU-PH, p.gorwood@ghu-paris.fr
- Recruiting
UDJ Michel Ange
Paris, 75016
Nathalie Godart, PU-PH, nathalie.godart@fsef.net
- Recruiting
CHU St Etienne
Saint-Etienne, 42000
Catherine Massoubre, Dr, catherine.massoubre@chu-st-etienne.fr
Baptiste Ravey, Dr, baptiste.ravey@chu-st-etienne.fr
About this study
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.
Read the detailed description
The project's hypothesis is adding an 8 weeks standardized 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.
Expected consequences of the study: demonstration that including adapted physical activity program in the global treatment program of anorexia nervosa is crucial in order to improve the therapeutic efficacy of the treatment acceptability, as drop out is usually important. In case of positive results, it will allow suppress interdiction in doing sport, source of conflict - and a way to enhance compliance to treatment which is difficult in anorexia nervosa to enable greater, earlier efficacy, which is predictive of more rapid recovery and avoid of chronicity.
Main Objective To evaluate in terms of Body Mass Index evolution at the end of the program, the efficacy of a 8 weeks standardized adapted physical activity program, designed for persons suffering from anorexia nervosa, including psychoeducation on both problematic physical activity and consequences and in terms of physical activity good practices.
Secondary Objectives To evaluate, at the end and 6 months later, the efficacy of a 8 week standardized Adapted Physical Activity program (including psychoeducation in terms of physical activity good practices designed for persons suffering from anorexia nervosa on both problematic physical activity and consequences), in terms of variation of body composition evaluated by bioelectric impedance (Fat mass and fat free mass), physical activity (duration, intensity, addiction, compulsion), fitness perceived (general fitness, cardio respiratory, strength, agility, flexibility ), self-esteem , perception of the body shape, quality of life both in terms of general and specific and eating disorders symptoms, level of anxiety symptoms, level of depressive symptoms, level of eating disorders symptoms, rate of drop-out from the global treatment program. To evaluate also the variation of BMI between base line and 6 months, and between 8 weeks and 6 months.
- Conditions
- Anorexia Nervosa
- Being tested
- Adapted physical activity program, Treatment as usual group
- Keywords
- Adapted physical activity
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activity programOther
Also called APA
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.
Treatment as usual groupOther
Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Treatment as usual group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion (start of research) and 9 week later (=T3)
Secondary outcomes (9)
Physical self Change
Physical Self-inventory
Measured: 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
Duration, intensity : Global Physical Activity Questionnaire (GPAQ)-
Measured: 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
Motivation for physical activity : Behavior Regulation Exercise Questionnaire (BREQ 3)
Measured: 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
Dependence : EXERCISE DEPENDENCE SCALE-REVISED (EDS-R)
Measured: 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
Self questionnaire : Body Shape Questionnaire
Measured: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Body image Matrix Of Thinness and Muscularity change
Self questionnaire : Body image Matrix Of Thinness and Muscularity
Measured: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Quality of life change
Self questionnaire : World Health Organization Quality of Life (Whoqol)
Measured: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Anxiety and depression symptoms and stress change
Psychometric properties of the Depression Anxiety Stress Scales (EDAS)
Measured: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2)
Eating disorders symptoms change
Eating Disorder Examination Questionnaire (EDE-Q)
Measured: Inclusion (start of research) and 8 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start14 Nov 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Godart, PU-PH, Study director, Fondation Santé des Étudiants de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477537
- Sponsor's protocol ID
- 2022-A00416-37
- Acronym
- EfAPA
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity in the Treatment of Anorexia:
- ClinicalTrials.gov ID
- NCT05477537
- Acronym / sponsor ID
- EfAPA / 2022-A00416-37
- Conditions
- Anorexia Nervosa
- Keywords
- Adapted physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jul 2022 (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.
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.
Detailed description
The project's hypothesis is adding an 8 weeks standardized 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.
Expected consequences of the study: demonstration that including adapted physical activity program in the global treatment program of anorexia nervosa is crucial in order to improve the therapeutic efficacy of the treatment acceptability, as drop out is usually important. In case of positive results, it will allow suppress interdiction in doing sport, source of conflict - and a way to enhance compliance to treatment which is difficult in anorexia nervosa to enable greater, earlier efficacy, which is predictive of more rapid recovery and avoid of chronicity.
Main Objective To evaluate in terms of Body Mass Index evolution at the end of the program, the efficacy of a 8 weeks standardized adapted physical activity program, designed for persons suffering from anorexia nervosa, including psychoeducation on both problematic physical activity and consequences and in terms of physical activity good practices.
Secondary Objectives To evaluate, at the end and 6 months later, the efficacy of a 8 week standardized Adapted Physical Activity program (including psychoeducation in terms of physical activity good practices designed for persons suffering from anorexia nervosa on both problematic physical activity and consequences), in terms of variation of body composition evaluated by bioelectric impedance (Fat mass and fat free mass), physical activity (duration, intensity, addiction, compulsion), fitness perceived (general fitness, cardio respiratory, strength, agility, flexibility ), self-esteem , perception of the body shape, quality of life both in terms of general and specific and eating disorders symptoms, level of anxiety symptoms, level of depressive symptoms, level of eating disorders symptoms, rate of drop-out from the global treatment program. To evaluate also the variation of BMI between base line and 6 months, and between 8 weeks and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Add-on group | Experimental | Other: Adapted physical activity programSubjects 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) |
| Treatment as usual group | Active comparator | Other: Treatment as usual groupSubjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual). |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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),
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 |
|---|---|---|
| Adapted physical activity programAlso: APAsubjects 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. | Other | Add-on group |
| Treatment as usual groupSubjects 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 |
Primary outcome
Body Mass Index change
Time frame: Inclusion (start of research) and 9 week later (=T3)
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.
9 secondary outcomes
Physical self Change
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Body image Matrix Of Thinness and Muscularity change
Time frame: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Quality of life change
Time frame: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Anxiety and depression symptoms and stress change
Time frame: First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2)
Eating disorders symptoms change
Time frame: Inclusion (start of research) and 8 month 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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Laurence Kern, MCU contact
Nathalie Godart, PU-PH study director
Fondation Santé des Étudiants de France
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity program and Treatment as usual group in people with Anorexia Nervosa, run by Fondation Santé des Étudiants de France at 7 sites 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 6 inclusion and 6 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Nathalie Godart, PU-PH (01.45.89.43.39, nathalie.godart@fsef.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index change (time frame: Inclusion (start of research) and 9 week later (=T3)). 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 28 Aug 2025.