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

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

Detailed Description
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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.

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

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: Home-based Adapted Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age between 18 and 30 years Subjects able to give informed consent Clinical diagnosis of restrictive anorexia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5: dietary restriction leading to low weight , intense fear of gaining weight, dysmorphophobia 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based Adapted Physical Activity<br>Home-based Adapted Physical Activity sessions by videoconference | Behavioral: Home-based Adapted Physical Activity<br>* There will be 8 weekly sessions at a time defined in advance for the same group and for the 8 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, telerehabilitation, Adapted Physical Activity