An interventional study of Adapted physical activity program and Treatment as usual group in Anorexia Nervosa, sponsored by Fondation Santé des Étudiants de France. Recruiting at 7 sites in France. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Fondation Santé des Étudiants de France · Not applicable, Interventional, and Treatment
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.
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.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 220 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Fondation Santé des Étudiants de France is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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
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
Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)
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)
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)
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)
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)
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)
Perception of the body shape change
Self questionnaire : Body Shape Questionnaire
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
Self questionnaire : Body image Matrix Of Thinness and Muscularity
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
Self questionnaire : World Health Organization Quality of Life (Whoqol)
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
Psychometric properties of the Depression Anxiety Stress Scales (EDAS)
Time frame: 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)
Time frame: Inclusion (start of research) and 8 month after inclusion
Not enrolling at this site.
Plan to share: No
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Started Nov 2023 (actual). Primary completion is estimated for Apr 2027, 41 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 41 months is close to that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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Fondation Santé des Étudiants de France