APAMAdom: Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
Study Details
Study Description
Brief Summary
The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home-based Adapted Physical Activity Home-based Adapted Physical Activity sessions by videoconference |
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
|
Outcome Measures
Primary Outcome Measures
- 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 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
- 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 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female gender
-
Age between 18 and 30 years
-
Subjects able to give informed consent
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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
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BMI < 18.5 kg/m2
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Affiliated in a social security plan
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Having given informed consent to the research
Exclusion Criteria:
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Indication for in-patient care or BMI < 12 kg/m2
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Subject presenting a contrindication to the practice of an adapted physical activity
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Anorexia nervosa in partial or complete remission for more than 1 year
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Patient unable, for technical or any other reason, to connect via the Internet for tele-monitoring and/or tele-rehabilitation
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Persons concerned by the articles L1121-5 to L1121-8 of the public health code
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Subjects who cannot be contacted in case of emergency
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Subjects in a period of exclusion from another study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cécile BETRY | Grenoble | France |
Sponsors and Collaborators
- University Hospital, Grenoble
- AGIR à Dom
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 38RC22.0097