NCT05803707

Brief Summary

The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

May 7, 2026

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

December 23, 2022

Last Update Submit

April 30, 2026

Conditions

Keywords

Anorexia NervosatelerehabilitationAdapted Physical Activity

Outcome Measures

Primary Outcomes (12)

  • Acceptability of a telerehabilitation adapted physical activity (APA) program for patient with anorexia nervosa quantitatively

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 )

Study Arms (1)

Home-based Adapted Physical Activity

EXPERIMENTAL

Home-based Adapted Physical Activity sessions by videoconference

Behavioral: Home-based Adapted Physical Activity

Interventions

There will be 8 weekly sessions at a time defined in advance for the same group and for the 8 sessions

Home-based Adapted Physical Activity

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cécile BETRY

Grenoble, France

Location

Pr GUILLAUME Sébastien

Montpellier, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2022

First Posted

April 7, 2023

Study Start

September 22, 2023

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

May 7, 2026

Record last verified: 2025-10

Locations