search
Back to results

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

Primary Purpose

Anorexia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted physical activity program
Treatment as usual group
Sponsored by
Fondation Santé des Étudiants de France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Adapted physical activity

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Lille
  • Clinique Saint Vincent de Paul
  • CHU Montpellier
  • CHU Nantes - service d'addictologie et Psychiatrie de Liaison
  • GHU Saine Anne
  • UDJ Michel Ange
  • CHU St Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Add-on group

Treatment as usual group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical self Change
Physical Self-inventory
Physical activity currently change
Duration, intensity : Global Physical Activity Questionnaire (GPAQ)-
Physical activity currently change
Motivation for physical activity : Behavior Regulation Exercise Questionnaire (BREQ 3)
Physical activity currently change
Dependence : EXERCISE DEPENDENCE SCALE-REVISED (EDS-R)
Perception of the body shape change
Self questionnaire : Body Shape Questionnaire
Body image Matrix Of Thinness and Muscularity change
Self questionnaire : Body image Matrix Of Thinness and Muscularity
Quality of life change
Self questionnaire : World Health Organization Quality of Life (Whoqol)
Anxiety and depression symptoms and stress change
Psychometric properties of the Depression Anxiety Stress Scales (EDAS)
Eating disorders symptoms change
Eating Disorder Examination Questionnaire (EDE-Q)

Full Information

First Posted
July 22, 2022
Last Updated
July 25, 2022
Sponsor
Fondation Santé des Étudiants de France
search

1. Study Identification

Unique Protocol Identification Number
NCT05477537
Brief Title
Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial
Acronym
EfAPA
Official Title
Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Santé des Étudiants de France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Adapted physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Add-on group
Arm Type
Experimental
Arm Description
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)
Arm Title
Treatment as usual group
Arm Type
Active Comparator
Arm Description
Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual).
Intervention Type
Other
Intervention Name(s)
Adapted physical activity program
Other Intervention Name(s)
APA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual group
Intervention Description
Subjects with Anorexia Nervosa involved in a day hospital or an inpatient program following HAS guidelines for AN treatment (treatment as usual)
Primary Outcome Measure Information:
Title
Body Mass Index change
Description
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 Outcome Measure Information:
Title
Physical self Change
Description
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)
Title
Physical activity currently change
Description
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)
Title
Physical activity currently change
Description
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)
Title
Physical activity currently change
Description
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)
Title
Perception of the body shape change
Description
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)
Title
Body image Matrix Of Thinness and Muscularity change
Description
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)
Title
Quality of life change
Description
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)
Title
Anxiety and depression symptoms and stress change
Description
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)
Title
Eating disorders symptoms change
Description
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame
Inclusion (start of research) and 8 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Godart, PU-PH
Phone
01.45.89.43.39
Email
nathalie.godart@fsef.net
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Kern, MCU
Email
laurence.kern@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Godart, PU-PH
Organizational Affiliation
Fondation Santé des Étudiants de France
Official's Role
Study Director
Facility Information:
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Vigneau, Dr
Email
jean.vigneau@chru-lille.fr
Facility Name
Clinique Saint Vincent de Paul
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Carrier
Email
louis.carrier@csvp.com
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Guillaume, Dr
Email
s-guillaume@chu-montpellier.fr
Facility Name
CHU Nantes - service d'addictologie et Psychiatrie de Liaison
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Grall, PU-PH
Email
marie.bronnec@chu-nantes.fr
Facility Name
GHU Saine Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Gorwood, PU-PH
Email
p.gorwood@ghu-paris.fr
Facility Name
UDJ Michel Ange
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Godart, PU-PH
Email
nathalie.godart@fsef.net
Facility Name
CHU St Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Massoubre, Dr
Email
catherine.massoubre@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Baptiste Ravey, Dr
Email
baptiste.ravey@chu-st-etienne.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs