Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study (APAMAdom)

April 30, 2026 updated by: University Hospital, Grenoble
The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main questions it aims to answer are: Determining the acceptability of this program / Determining the feasibility and safety of this program / Determining patient satisfaction / Measuring the evolution of the symptomatology. Participants will follow a program of Home-based Adapted Physical Activity.

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

  • France
      • Grenoble, France
        • Cécile BETRY
      • Montpellier, France
        • Pr GUILLAUME Sébastien

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female gender
  • Age between 18 and 60 years
  • Subjects able to give informed consent
  • Eating disorders such as anorexia nervosa
  • BMI < 18.5 kg/m2
  • Affiliated in a social security plan
  • Having given informed consent to the research

Exclusion Criteria:

  • Indication for in-patient care or BMI < 12 kg/m2
  • Subject presenting a contrindication to the practice of an adapted physical activity
  • Anorexia nervosa in partial or complete remission for more than 1 year
  • Patient unable, for technical or any other reason, to connect via the Internet for tele-monitoring and/or tele-rehabilitation
  • Persons concerned by the articles L1121-5 to L1121-8 of the public health code
  • Subjects who cannot be contacted in case of emergency
  • Subjects in a period of exclusion from another study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based Adapted Physical Activity
Home-based Adapted Physical Activity sessions by videoconference
Behavioral: Home-based Adapted Physical Activity
There will be 8 weekly sessions at a time defined in advance for the same group and for the 8 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of a telerehabilitation adapted physical activity (APA) program for patient with anorexia nervosa quantitatively
Time Frame: at the first session of the APA program (Day 0)
Number of patients who have realized the first of the 8 adapted physical activity session in relation to the total number of eligibly patients who have been invited to participate at the study
at the first session of the APA program (Day 0)
Acceptability of a telerehabilitation adapted physical activity program for patient with anorexia nervosa qualitively
Time Frame: at the first session of the APA program (Day 0)
Reasons for refusal and participation's age will be collected anonymously for patients who refuse inclusion but agree to this informations being collected
at the first session of the APA program (Day 0)
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
Time Frame: at the end-of-study visit (Day 0 + 11 weeks)
Number and portion of patients who have realized the 8 adapted physical activity sessions as well as the first and final sessions
at the end-of-study visit (Day 0 + 11 weeks)
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
Time Frame: at the end-of-study visit (Day 0 + 11 weeks)
Motifs of no realization of one ou more sessions will be collected. They will inclued technical problems, personal, professional ou medical constraints inclued study's exit for weight loss
at the end-of-study visit (Day 0 + 11 weeks)
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
Time Frame: at the final session of APA programm (Day 0 + 8 weeks)
Portion of patients answing "yes" at the question : "Would you like to continue this program ?"
at the final session of APA programm (Day 0 + 8 weeks)
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
Time Frame: at the final session of APA programm (Day 0 + 8 weeks)
Programm's motifs of satisfaction or no satisfaction will be collected during the final session of adapted physical activity program
at the final session of APA programm (Day 0 + 8 weeks)
Measuring changes in symptomatology in key areas such as self-esteem through self-assessment questionnaire
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parameter :self-esteem by self-esteem scale of Rosenberg
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Measuring changes in symptomatology in key areas such as quality of life through self-assessment questionnaire
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parametes :quality of life by QUAVIAM scale
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Measuring changes in symptomatology in key areas such as dependence on physical activity through self-assessment questionnaire
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parameter : dependence on physical activity by EDQ questionnary
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Measuring changes in symptomatology in key areas such as dependence on physical activity through objective measure
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parameter : level of physical activity by 7-day actimetry recording
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Measuring changes in symptomatology in key areas such as changes in weight through objective measure
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parameter : weight in kilograms on a classic scale
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Measuring changes in symptomatology in key areas such as body composition through objective measure
Time Frame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Determination of this parameters : the body composition will be determinated by a impedancemetry measurement
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Collaborators

AGIR à Dom

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 (Actual)

September 22, 2023

Primary Completion (Actual)

August 28, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0097

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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