Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial

Anorexia Nervosa Clinical Trial

— EfAPA  

Official title:

Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477537
• Other study ID #: 2022-A00416-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2022
• Source: Fondation Santé des Étudiants de France
• Contact: Nathalie Godart, PU-PH
• Phone: 01.45.89.43.39
• Email: nathalie.godart[@]fsef.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: August 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Adapted physical activity program
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 group
Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)

Locations

Country	Name	City	State
France	CHU Lille	Lille
France	Clinique Saint Vincent de Paul	Lyon
France	CHU Montpellier	Montpellier
France	CHU Nantes - service d'addictologie et Psychiatrie de Liaison	Nantes
France	GHU Saine Anne	Paris
France	UDJ Michel Ange	Paris
France	CHU St Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Santé des Étudiants de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical self Change	Physical Self-inventory	First program session (T1= one week after inclusion) / 8 week later T1 (end of program = T2) / 6 month after T2 (=T4)
Secondary	Physical activity currently change	Duration, intensity : Global Physical Activity Questionnaire (GPAQ)-	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) /6 month after T2 (=T4)
Secondary	Physical activity currently change	Motivation for physical activity : Behavior Regulation Exercise Questionnaire (BREQ 3)	First program session (T1= one week after inclusion) /8 week later T1 (end of program=T2) /6 month after T2 (=T4)
Secondary	Physical activity currently change	Dependence : EXERCISE DEPENDENCE SCALE-REVISED (EDS-R)	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Secondary	Perception of the body shape change	Self questionnaire : Body Shape Questionnaire	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Secondary	Body image Matrix Of Thinness and Muscularity change	Self questionnaire : Body image Matrix Of Thinness and Muscularity	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Secondary	Quality of life change	Self questionnaire : World Health Organization Quality of Life (Whoqol)	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2) / 6 month after T2 (=T4)
Secondary	Anxiety and depression symptoms and stress change	Psychometric properties of the Depression Anxiety Stress Scales (EDAS)	First program session (T1= one week after inclusion) / 8 week later T1 (end of program=T2)
Secondary	Eating disorders symptoms change	Eating Disorder Examination Questionnaire (EDE-Q)	Inclusion (start of research) and 8 month after inclusion