An interventional study of Adapted Physical Activity (APA) in Anorexia Nervosa, Exercise Therapy and Videoconferencing, sponsored by University Hospital, Caen. Active, not recruiting at 1 site in France. Open to female participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Supportive care
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:
The secondary objectives are to evaluate the impact of this program on :
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).
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.
455 studies on the registry are indexed under Anorexia Nervosa; 126 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 305 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care.
Other: Adapted Physical Activity (APA)
The group without additional intervention other than the outpatient care.
A 8-weeks program of APA (2x1hour per week) via videoconferencing composed of resistance training and yoga.
Also known as: Interventional exercise therapy
Treatment Acceptability and Preferences questionnaire (TAP-Q)
Questionnaire (scale) assessing the acceptability of the APA program via videoconferencing (high score mean better outcome).
Time frame: 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).
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)
Hospital Anxiety and Depression (HAD) scale
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)
Rosenberg Self-esteem Scale (RSS)
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)
Contour Drawing Rating Scale (CDRS)
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)
Body Esteem Scale (BES)
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)
Exercise Dependence Scale Revised
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)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
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)
Pittsburgh Sleep Quality Index (PSQI)
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)
Actimetry
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)
Body Mass Index (BMI)
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)
Body composition - Body cellular mass
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)
Body composition - Fat mass
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)
Body composition - Fat free mass
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)
Body composition - Total body water
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)
Body composition - Extracellular water
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)
Isokinetic assessment of upper and lower limbs
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)
Back extension strength
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)
Shirado test
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)
Sorensen test
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)
Plan to share: No
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University Hospital, Caen