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Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study (APAREXIM-P)

Primary Purpose

Anorexia Nervosa, Exercise Therapy, Videoconferencing

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted Physical Activity (APA)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia Nervosa focused on measuring eating disorders, anorexia nervosa, physical activity, exercise, psychiatry, mental health, muscle strength, chronobiology, physical condition, adolescent, pediatric, videoconferencing

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patient between 13 and 18 years old, with typical anorexia nervosa symptoms diagnosed by a specialist. Patient followed in outpatient care. Collection of the signature of the informed consent. Patient affiliated to the health insurance system. Agreement of the legal representatives Exclusion Criteria: Patient with contraindications to physical activity or with a state of health judged critical by the doctor. Person deprived of liberty by judicial or administrative decision, or under guardianship or curatorship. Pregnant or breast-feeding woman. Patient included in another biomedical research protocol during the present study.

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AM-APA

AM-T

Arm Description

The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care.

The group without additional intervention other than the outpatient care.

Outcomes

Primary Outcome Measures

Treatment Acceptability and Preferences questionnaire (TAP-Q)
Questionnaire (scale) assessing the acceptability of the APA program via videoconferencing (high score mean better outcome).
Eating Attitude Test - 26 (EAT-26)
Questionnaire (scale) assessing the severity of main anorexic symptoms (high score mean worse outcome).

Secondary Outcome Measures

Hospital Anxiety and Depression (HAD) scale
Questionnaire (scale) assessing anxious and depressive symptoms (high score mean worse outcome).
Rosenberg Self-esteem Scale (RSS)
Questionnaire (scale) assessing self-esteem (high score mean better outcome).
Contour Drawing Rating Scale (CDRS)
Questionnaire (scale) assessing self-esteem (high score mean worse outcome).
Body Esteem Scale (BES)
Questionnaire (scale) assessing body esteem (high score mean better outcome).
Exercise Dependence Scale Revised
Questionnaire (scale) assessing exercise dependence (high score mean worse outcome).
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Questionnaire (scale) assessing interoceptive awareness (high score mean better outcome).
Pittsburgh Sleep Quality Index (PSQI)
Questionnaire (scale) assessing sleep quality (high score mean worse outcome).
Actimetry
One week of actimetry with an accelerometer watch measuring 7x24h activity counts allowing to extract day and night activity level.
Body Mass Index (BMI)
Measure of body weight and height to compute the BMI
Body composition - Body cellular mass
Bio-impedance measuring of body cellular mass
Body composition - Fat mass
Bio-impedance measuring of body fat mass
Body composition - Fat free mass
Bio-impedance measuring of body fat-free mass
Body composition - Total body water
Bio-impedance measuring of total body water
Body composition - Extracellular water
Bio-impedance measuring of body extracellular water
Isokinetic assessment of upper and lower limbs
Isokinetic peak torque (concentric contraction at 60°/sec and 240°/sec) of forearm and leg flexion/extension.
Back extension strength
Assessment of the back extension strength with a dynamometer
Shirado test
Assessment of the isometric back flexion endurance with the Shirado test
Sorensen test
Assessment of the isometric back extension endurance with the Sorensen test

Full Information

First Posted
December 13, 2022
Last Updated
March 3, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05770089
Brief Title
Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study
Acronym
APAREXIM-P
Official Title
Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of the APAREXIM'Pilot study are to evaluate the short- and medium-term effects of a live supervised Adapted Physical Activity (APA) program via videoconferencing on: Feasibility and acceptability of APA via videoconferencing by the patients. The primary symptoms of Anorexia Nervosa (AN). The secondary objectives are to evaluate the impact of this program on : Mental health Physical condition Sleep-wake cycle (sleep disturbance and physical hyperactivity) The patients will first undergo an inclusion visit (T0) at the University Hospital of Caen, then a first evaluation session (T1) at the COMETE laboratory in Caen (physical tests, questionnaires, sleep diary, actimetry). They will then be randomly divided into 2 groups: 15 patients who will follow an APA program supervised by videoconference for 8 weeks (AM-APA) at their home, in addition to the usual outpatient treatment, and 15 patients who will benefit only from the classic outpatient treatment (AM-T). All patients will undergo two additional evaluation sessions at one week post-program (T2) and at 3 months post-program (T3).
Detailed Description
Background: Anorexia nervosa (AN) is an eating disorder (ED), mainly in women, characterized by strict and voluntary food deprivation over a long period of time, which can last from several months to several years, leading to significant weight loss. This disease affects 2.2 to 4% of the general population in Europe and is one of the most fatal psychiatric diseases in people under 25 years old. Physiological and psychological disorders are very often associated with AN, as well as an alteration of the sleep-wake cycle. In order to reduce the risk of chronicity of the disease and to prevent its various complications in young women, early and multidisciplinary therapeutic management is recommended by public health authorities. However, this management remains long and complex due to the diversity and severity of the symptoms, a lack of adherence of patients to treatment protocols, but also a lack of therapeutic continuity after hospitalization. Recently, new non-medicinal therapies based on Adapted Physical Activity (APA) have been developed to prevent and reduce the main symptoms of AN and associated disorders in an effective and lasting way. However, to our knowledge, interventional research in this field remains scarce and presents limited results. Furthermore, the scientific literature does not report any evaluation of the feasibility, acceptability, and effectiveness of a home video-conference-supervised APA intervention with AN patients. Objectives: The primary objectives of the APAREXIM'Pilot study are to evaluate the short- and medium-term effects of a live supervised APA program via videoconferencing on feasibility and acceptability of APA via videoconferencing by the patients and the primary symptoms of AN. The secondary objectives are to evaluate the impact of this program on mental health, physical condition and the sleep-wake cycle (sleep disturbance and physical hyperactivity), as well as its. Method: This randomized controlled intervention study will be conducted with 30 adolescent and young adult girls with AN. The patients will first undergo an inclusion visit (T0) at the University Hospital of Caen, then a first evaluation session (T1) at the COMETE laboratory in Caen (physical tests, questionnaires, sleep diary, actimetry). They will then be randomly divided into 2 groups: 15 patients who will follow an APA program supervised by videoconference for 8 weeks (AM-APA) at their home, in addition to the usual outpatient treatment, and 15 patients who will benefit only from the classic outpatient treatment (AM-T). All patients will undergo two additional evaluation sessions at one week post-program (T2) and at 3 months post-program (T3). Perspectives: The results obtained will allow to evaluate the acceptability and the feasibility of a distance APA program, and to bring additional evidence of the effectiveness of an APA intervention in patients with AM, as well as elements of understanding of the regulation of this pathology by APA. In addition, the APAREXIM'Pilot study will allow to test and validate an APA program for patients with AM, which could eventually be integrated in the management of patients on the national territory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Exercise Therapy, Videoconferencing
Keywords
eating disorders, anorexia nervosa, physical activity, exercise, psychiatry, mental health, muscle strength, chronobiology, physical condition, adolescent, pediatric, videoconferencing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AM-APA
Arm Type
Experimental
Arm Description
The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care.
Arm Title
AM-T
Arm Type
No Intervention
Arm Description
The group without additional intervention other than the outpatient care.
Intervention Type
Other
Intervention Name(s)
Adapted Physical Activity (APA)
Other Intervention Name(s)
Interventional exercise therapy
Intervention Description
A 8-weeks program of APA (2x1hour per week) via videoconferencing composed of resistance training and yoga.
Primary Outcome Measure Information:
Title
Treatment Acceptability and Preferences questionnaire (TAP-Q)
Description
Questionnaire (scale) assessing the acceptability of the APA program via videoconferencing (high score mean better outcome).
Time Frame
T2 (just after the APA program)
Title
Eating Attitude Test - 26 (EAT-26)
Description
Questionnaire (scale) assessing the severity of main anorexic symptoms (high score mean worse outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression (HAD) scale
Description
Questionnaire (scale) assessing anxious and depressive symptoms (high score mean worse outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Rosenberg Self-esteem Scale (RSS)
Description
Questionnaire (scale) assessing self-esteem (high score mean better outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Contour Drawing Rating Scale (CDRS)
Description
Questionnaire (scale) assessing self-esteem (high score mean worse outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body Esteem Scale (BES)
Description
Questionnaire (scale) assessing body esteem (high score mean better outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Exercise Dependence Scale Revised
Description
Questionnaire (scale) assessing exercise dependence (high score mean worse outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Description
Questionnaire (scale) assessing interoceptive awareness (high score mean better outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Questionnaire (scale) assessing sleep quality (high score mean worse outcome).
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Actimetry
Description
One week of actimetry with an accelerometer watch measuring 7x24h activity counts allowing to extract day and night activity level.
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body Mass Index (BMI)
Description
Measure of body weight and height to compute the BMI
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body composition - Body cellular mass
Description
Bio-impedance measuring of body cellular mass
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body composition - Fat mass
Description
Bio-impedance measuring of body fat mass
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body composition - Fat free mass
Description
Bio-impedance measuring of body fat-free mass
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body composition - Total body water
Description
Bio-impedance measuring of total body water
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Body composition - Extracellular water
Description
Bio-impedance measuring of body extracellular water
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Isokinetic assessment of upper and lower limbs
Description
Isokinetic peak torque (concentric contraction at 60°/sec and 240°/sec) of forearm and leg flexion/extension.
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Back extension strength
Description
Assessment of the back extension strength with a dynamometer
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Shirado test
Description
Assessment of the isometric back flexion endurance with the Shirado test
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Title
Sorensen test
Description
Assessment of the isometric back extension endurance with the Sorensen test
Time Frame
Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patient between 13 and 18 years old, with typical anorexia nervosa symptoms diagnosed by a specialist. Patient followed in outpatient care. Collection of the signature of the informed consent. Patient affiliated to the health insurance system. Agreement of the legal representatives Exclusion Criteria: Patient with contraindications to physical activity or with a state of health judged critical by the doctor. Person deprived of liberty by judicial or administrative decision, or under guardianship or curatorship. Pregnant or breast-feeding woman. Patient included in another biomedical research protocol during the present study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian GUENOLE, MD PhD Pr
Organizational Affiliation
Caen Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study

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