Adapted Physical Activity in the Treatment of Anorexia:
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-40
SponsorFondation Santé des Étudiants de France
About this trial
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
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Adapted physical activity program
Other interventionsubjects 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 group
Other interventionSubjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Add-on groupExperimental treatment 1 intervention
Group B: Treatment as usual groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Inclusion (start of research) and 9 week later (=T3)Secondary outcomes
1
Physical self Change
Physical Self-inventory
Time frame
First program session (T1= one week after inclusion) / 8 week later T1 (end of program = T2) / 6 month after T2 (=T4)2
Physical activity currently change
Duration, intensity : Global Physical Activity Questionnaire (GPAQ)-
Time frame
First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) /6 month after T2 (=T4)3
Physical activity currently change
Motivation for physical activity : Behavior Regulation Exercise Questionnaire (BREQ 3)
Time frame
First program session (T1= one week after inclusion) /8 week later T1 (end of program=T2) /6 month after T2 (=T4)4
Physical activity currently change
Dependence : EXERCISE DEPENDENCE SCALE-REVISED (EDS-R)
Time frame
First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov