Back to resultsHome-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study (APAMAdom)
Primary Purpose
Anorexia Nervosa
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Home-based Adapted Physical Activity
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, telerehabilitation, Adapted Physical Activity
Eligibility Criteria
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
Sites / Locations
- Cécile BETRY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-based Adapted Physical Activity
Arm Description
Home-based Adapted Physical Activity sessions by videoconference
Outcomes
Primary Outcome Measures
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
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
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
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
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 ?"
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
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
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05803707
First Posted
December 23, 2022
Last Updated
March 24, 2023
Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom
1. Study Identification
Unique Protocol Identification Number
NCT05803707
Brief Title
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
Acronym
APAMAdom
Official Title
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia Nervosa, telerehabilitation, Adapted Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based Adapted Physical Activity
Arm Type
Experimental
Arm Description
Home-based Adapted Physical Activity sessions by videoconference
Intervention Type
Behavioral
Intervention Name(s)
Home-based Adapted Physical Activity
Intervention Description
There will be 8 weekly sessions at a time defined in advance for the same group and for the 8 sessions
Primary Outcome Measure Information:
Title
Acceptability of a telerehabilitation adapted physical activity (APA) program for patient with anorexia nervosa quantitatively
Description
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
Time Frame
at the first session of the APA program (Day 0)
Title
Acceptability of a telerehabilitation adapted physical activity program for patient with anorexia nervosa qualitively
Description
Reasons for refusal and participation's age will be collected anonymously for patients who refuse inclusion but agree to this informations being collected
Time Frame
at the first session of the APA program (Day 0)
Title
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
Description
Number and portion of patients who have realized the 8 adapted physical activity sessions as well as the first and final sessions
Time Frame
at the end-of-study visit (Day 0 + 11 weeks)
Title
Feasibility and safety of a telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
Description
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
Time Frame
at the end-of-study visit (Day 0 + 11 weeks)
Title
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa quantitatively
Description
Portion of patients answing "yes" at the question : "Would you like to continue this program ?"
Time Frame
at the final session of APA programm (Day 0 + 8 weeks)
Title
Patient satisfaction with the telerehabilitation adapted physical activity program for patients with anorexia nervosa qualitively
Description
Programm's motifs of satisfaction or no satisfaction will be collected during the final session of adapted physical activity program
Time Frame
at the final session of APA programm (Day 0 + 8 weeks)
Title
Measuring changes in symptomatology in key areas such as self-esteem through self-assessment questionnaire
Description
Determination of this parameter :self-esteem by self-esteem scale of Rosenberg
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Title
Measuring changes in symptomatology in key areas such as quality of life through self-assessment questionnaire
Description
Determination of this parametes :quality of life by QUAVIAM scale
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Title
Measuring changes in symptomatology in key areas such as dependence on physical activity through self-assessment questionnaire
Description
Determination of this parameter : dependence on physical activity by EDQ questionnary
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Title
Measuring changes in symptomatology in key areas such as dependence on physical activity through objective measure
Description
Determination of this parameter : level of physical activity by 7-day actimetry recording
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Title
Measuring changes in symptomatology in key areas such as changes in weight through objective measure
Description
Determination of this parameter : weight in kilograms on a classic scale
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
Title
Measuring changes in symptomatology in key areas such as body composition through objective measure
Description
Determination of this parameters : the body composition will be determinated by a impedancemetry measurement
Time Frame
at the early study visit (Day 0 - 4 weeks) and at end-of-study visit (Day 0 + 11 weeks )
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile BETRY, MCU PH
Phone
+33476763736
Email
cbetry@chu-grenoble.fr
Facility Information:
Facility Name
Cécile BETRY
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile BETRY, MCU PH
Phone
+33476763736
Email
cbetry@chu-grenoble.fr
12. IPD Sharing Statement
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Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
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