Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
APAMAdom
1 other identifier
interventional
36
1 country
2
Brief Summary
The goal of this pilot clinical trial is to assess a program of Home-based Adapted Physical Activity in Anorexia Nervosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2025
CompletedMay 7, 2026
October 1, 2025
1.9 years
December 23, 2022
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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 )
Study Arms (1)
Home-based Adapted Physical Activity
EXPERIMENTALHome-based Adapted Physical Activity sessions by videoconference
Interventions
There will be 8 weekly sessions at a time defined in advance for the same group and for the 8 sessions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- AGIR à Domcollaborator
Study Sites (2)
Cécile BETRY
Grenoble, France
Pr GUILLAUME Sébastien
Montpellier, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2022
First Posted
April 7, 2023
Study Start
September 22, 2023
Primary Completion
August 28, 2025
Study Completion
August 28, 2025
Last Updated
May 7, 2026
Record last verified: 2025-10