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

July 25, 2022 updated by: Fondation Santé des Étudiants de France

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Add-on 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)
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.
Other Names:
  • APA
Active Comparator: 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).
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Inclusion (start of research) and 9 week later (=T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Self-inventory
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Eating disorders symptoms change
Time Frame: Inclusion (start of research) and 8 month after inclusion
Eating Disorder Examination Questionnaire (EDE-Q)
Inclusion (start of research) and 8 month after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Santé des Étudiants de France

Investigators

  • Study Director: Nathalie Godart, PU-PH, Fondation Santé des Étudiants de France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00416-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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