Anorexia Nervosa
Conditions
Keywords
Anorexia Nervosa, telerehabilitation, Adapted Physical Activity
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.
Interventions
BEHAVIORALHome-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
Sponsors
University Hospital, Grenoble
AGIR à Dom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed