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

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa

• Registration Number: NCT05803707
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-07
• Study Start: 2023-09-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-03-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measuring changes in symptomatology in key areas such as dependence on physical activity through objective measure	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
Measuring changes in symptomatology in key areas such as changes in weight through objective measure	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
Measuring changes in symptomatology in key areas such as self-esteem through self-assessment questionnaire	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
Acceptability of a telerehabilitation adapted physical activity (APA) program for patient with anorexia nervosa quantitatively	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
Acceptability of a telerehabilitation adapted physical activity program for patient with anorexia nervosa qualitively	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
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively	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
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively	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
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively	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 ?"
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively	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
Measuring changes in symptomatology in key areas such as quality of life through self-assessment questionnaire	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
Measuring changes in symptomatology in key areas such as dependence on physical activity through self-assessment questionnaire	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
Measuring changes in symptomatology in key areas such as body composition through objective measure	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

Trial Locations

Locations (2)

Cécile BETRY; 🇫🇷 Grenoble, France

Pr GUILLAUME Sébastien; 🇫🇷 Montpellier, France