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Completed

NCT Number: NCT05803707

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cécile BETRY, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Adapted Physical Activity

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 ?"

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom

Registry information

Acronym: APAMAdom

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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