Clinical trial NCT05803707: Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
Official title: Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
telerehabilitation
Adapted Physical Activity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
First posted: 2023-04-07
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of a telerehabilitation adapted physical activity (APA) program for patient with anorexia nervosa quantitatively
timeFrame: at the first session of the APA program (Day 0)
measure: Acceptability of a telerehabilitation adapted physical activity program for patient with anorexia nervosa qualitively
timeFrame: at the first session of the APA program (Day 0)
measure: Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
timeFrame: at the end-of-study visit (Day 0 + 11 weeks)
measure: Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
timeFrame: at the end-of-study visit (Day 0 + 11 weeks)
measure: Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
timeFrame: at the final session of APA programm (Day 0 + 8 weeks)
measure: Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
timeFrame: at the final session of APA programm (Day 0 + 8 weeks)
measure: Measuring changes in symptomatology in key areas such as self-esteem through self-assessment questionnaire
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
measure: Measuring changes in symptomatology in key areas such as quality of life through self-assessment questionnaire
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
measure: Measuring changes in symptomatology in key areas such as dependence on physical activity through self-assessment questionnaire
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
measure: Measuring changes in symptomatology in key areas such as dependence on physical activity through objective measure
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
measure: Measuring changes in symptomatology in key areas such as changes in weight through objective measure
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
measure: Measuring changes in symptomatology in key areas such as body composition through objective measure
timeFrame: at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Cécile BETRY
city: Montpellier
country: France
facility: Pr GUILLAUME Sébastien
Study officials:
References: