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Anorexia NervosaAPAREXIM-PNCT05770089

Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study

A study testing Adapted Physical Activity (APA) in people with Anorexia Nervosa and Exercise Therapy, run by University Hospital, Caen at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 13 to 18 years, women only
What is being tested?
Adapted Physical Activity (APA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
1 Dec 2022to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Caen University Hospital

    Caen, Calvados, 14033

Other trials in France

About this study

Official title: Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With 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).
Read more

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).

Read the 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.

Being tested
Adapted Physical Activity (APA)
Keywords
eating disorders, anorexia nervosa, physical activity, exercise, psychiatry, mental health, muscle strength, chronobiology, physical condition, adolescent, pediatric, videoconferencing
Medical subject headings
Anorexia Nervosa, Feeding and Eating Disorders, Motor Activity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Physical Activity (APA)Other

    Also called Interventional exercise therapy

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

Study groups in NCT05770089
Study groupRoleWhat they receive
AM-APAExperimentalThe group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care.
Receives: Other: Adapted Physical Activity (APA)
AM-TNo interventionThe group without additional intervention other than the outpatient care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: T2 (just after the APA program)

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

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

Secondary outcomes (18)
  1. Hospital Anxiety and Depression (HAD) scale

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  2. Rosenberg Self-esteem Scale (RSS)

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  3. Contour Drawing Rating Scale (CDRS)

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  4. Body Esteem Scale (BES)

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  5. Exercise Dependence Scale Revised

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA)

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  7. Pittsburgh Sleep Quality Index (PSQI)

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  8. Actimetry

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  9. Body Mass Index (BMI)

    Measure of body weight and height to compute the BMI

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  10. Body composition - Body cellular mass

    Bio-impedance measuring of body cellular mass

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  11. Body composition - Fat mass

    Bio-impedance measuring of body fat mass

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  12. Body composition - Fat free mass

    Bio-impedance measuring of body fat-free mass

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  13. Body composition - Total body water

    Bio-impedance measuring of total body water

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  14. Body composition - Extracellular water

    Bio-impedance measuring of body extracellular water

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  15. Isokinetic assessment of upper and lower limbs

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

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  16. Back extension strength

    Assessment of the back extension strength with a dynamometer

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  17. Shirado test

    Assessment of the isometric back flexion endurance with the Shirado test

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  18. Sorensen test

    Assessment of the isometric back extension endurance with the Sorensen test

    Measured: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05770089
Sponsor's protocol ID
2022-A01245-38
Acronym
APAREXIM-P
Status last verified
Jul 2025
First submitted
13 Dec 2022
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Physical Activity (APA) in people with Anorexia Nervosa and Exercise Therapy, run by University Hospital, Caen at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Acceptability and Preferences questionnaire (TAP-Q) (time frame: T2 (just after the APA program)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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