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

Anorexia Nervosa Clinical Trial

— APAMAdom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803707
• Other study ID #: 38RC22.0097
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: Cécile BETRY, MCU PH
• Phone: +33476763736
• Email: cbetry[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Locations

Country	Name	City	State
France	Cécile BETRY	Grenoble
France	Pr GUILLAUME Sébastien	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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 )
Primary	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 )
Primary	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 )
Primary	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 )
Primary	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 )
Primary	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 )