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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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