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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05770089
Other study ID # 2022-A01245-38
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2, 2022
Est. completion date December 1, 2026

Study information

Verified date February 2024
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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).


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.


Recruitment information / eligibility

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.

Study Design


Intervention

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

Locations

Country Name City State
France Caen University Hospital Caen Calvados

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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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