Anorexia Nervosa Clinical Trial
— APAREXIM-POfficial title:
Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study
Verified date | February 2024 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2026 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 13 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital | Caen | Calvados |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Acceptability and Preferences questionnaire (TAP-Q) | Questionnaire (scale) assessing the acceptability of the APA program via videoconferencing (high score mean better outcome). | T2 (just after the APA program) | |
Primary | Eating Attitude Test - 26 (EAT-26) | Questionnaire (scale) assessing the severity of main anorexic symptoms (high score mean worse outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Hospital Anxiety and Depression (HAD) scale | Questionnaire (scale) assessing anxious and depressive symptoms (high score mean worse outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Rosenberg Self-esteem Scale (RSS) | Questionnaire (scale) assessing self-esteem (high score mean better outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Contour Drawing Rating Scale (CDRS) | Questionnaire (scale) assessing self-esteem (high score mean worse outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body Esteem Scale (BES) | Questionnaire (scale) assessing body esteem (high score mean better outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Exercise Dependence Scale Revised | Questionnaire (scale) assessing exercise dependence (high score mean worse outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Multidimensional Assessment of Interoceptive Awareness (MAIA) | Questionnaire (scale) assessing interoceptive awareness (high score mean better outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Questionnaire (scale) assessing sleep quality (high score mean worse outcome). | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Actimetry | One week of actimetry with an accelerometer watch measuring 7x24h activity counts allowing to extract day and night activity level. | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body Mass Index (BMI) | Measure of body weight and height to compute the BMI | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body composition - Body cellular mass | Bio-impedance measuring of body cellular mass | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body composition - Fat mass | Bio-impedance measuring of body fat mass | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body composition - Fat free mass | Bio-impedance measuring of body fat-free mass | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body composition - Total body water | Bio-impedance measuring of total body water | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Body composition - Extracellular water | Bio-impedance measuring of body extracellular water | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Isokinetic assessment of upper and lower limbs | Isokinetic peak torque (concentric contraction at 60°/sec and 240°/sec) of forearm and leg flexion/extension. | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Back extension strength | Assessment of the back extension strength with a dynamometer | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Shirado test | Assessment of the isometric back flexion endurance with the Shirado test | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) | |
Secondary | Sorensen test | Assessment of the isometric back extension endurance with the Sorensen test | Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program) |
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