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.
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
- Conditions the study is for
- Anorexia Nervosa, Exercise Therapy, Videoconferencing
- 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.
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.
- Conditions
- Anorexia Nervosa, Exercise Therapy, Videoconferencing
- 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 group | Role | What they receive |
|---|---|---|
| AM-APA | Experimental | The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care. Receives: Other: Adapted Physical Activity (APA) |
| AM-T | No intervention | The 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted15 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabian GUENOLE, MD PhD Pr, Principal investigator, Caen Hospital University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study
- ClinicalTrials.gov ID
- NCT05770089
- Acronym / sponsor ID
- APAREXIM-P / 2022-A01245-38
- Conditions
- Anorexia Nervosa, Exercise Therapy, Videoconferencing
- Keywords
- eating disorders, anorexia nervosa, physical activity, exercise, psychiatry, mental health, muscle strength, chronobiology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM-APA | Experimental | Other: Adapted Physical Activity (APA)The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care. |
| AM-T | No intervention | –The group without additional intervention other than the outpatient care. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical Activity (APA)Also: Interventional exercise therapyA 8-weeks program of APA (2x1hour per week) via videoconferencing composed of resistance training and yoga. | Other | AM-APA |
Primary outcome
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).
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).
18 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabian GUENOLE, MD PhD Pr principal investigator
Caen Hospital University
1 site in 1 country: see every site and its status.
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.