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NCT Number: NCT05770089

Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, Calvados, 14033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted Physical Activity (APA)

Other

A 8-weeks program of APA (2x1hour per week) via videoconferencing composed of resistance training and yoga.

Other names: Interventional exercise therapy

Primary outcomes

  1. Treatment Acceptability and Preferences questionnaire (TAP-Q)

    Time frame: T2 (just after the APA program)

    Questionnaire (scale) assessing the acceptability of the APA program via videoconferencing (high score mean better outcome).

  2. Eating Attitude Test - 26 (EAT-26)

    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)

    Questionnaire (scale) assessing the severity of main anorexic symptoms (high score mean worse outcome).

Secondary outcomes

  1. Hospital Anxiety and Depression (HAD) scale

    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)

    Questionnaire (scale) assessing anxious and depressive symptoms (high score mean worse outcome).

  2. Rosenberg Self-esteem Scale (RSS)

    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)

    Questionnaire (scale) assessing self-esteem (high score mean better outcome).

  3. Contour Drawing Rating Scale (CDRS)

    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)

    Questionnaire (scale) assessing self-esteem (high score mean worse outcome).

  4. Body Esteem Scale (BES)

    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)

    Questionnaire (scale) assessing body esteem (high score mean better outcome).

  5. Exercise Dependence Scale Revised

    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)

    Questionnaire (scale) assessing exercise dependence (high score mean worse outcome).

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    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)

    Questionnaire (scale) assessing interoceptive awareness (high score mean better outcome).

  7. Pittsburgh Sleep Quality Index (PSQI)

    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)

    Questionnaire (scale) assessing sleep quality (high score mean worse outcome).

  8. Actimetry

    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)

    One week of actimetry with an accelerometer watch measuring 7x24h activity counts allowing to extract day and night activity level.

  9. Body Mass Index (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)

    Measure of body weight and height to compute the BMI

  10. Body composition - 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)

    Bio-impedance measuring of body cellular mass

  11. Body composition - 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)

    Bio-impedance measuring of body fat mass

  12. Body composition - 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)

    Bio-impedance measuring of body fat-free mass

  13. Body composition - 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)

    Bio-impedance measuring of total body water

  14. Body composition - 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)

    Bio-impedance measuring of body extracellular water

  15. Isokinetic assessment of upper and lower limbs

    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)

    Isokinetic peak torque (concentric contraction at 60°/sec and 240°/sec) of forearm and leg flexion/extension.

  16. Back extension strength

    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)

    Assessment of the back extension strength with a dynamometer

  17. 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)

    Assessment of the isometric back flexion endurance with the Shirado test

  18. 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)

    Assessment of the isometric back extension endurance with the Sorensen test

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study

Acronym: APAREXIM-P

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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