Clinical trial NCT05770089: Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study
Official title: Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Exercise Therapy
Videoconferencing
Keywords: eating disorders
anorexia nervosa
physical activity
exercise
psychiatry
mental health
muscle strength
chronobiology
physical condition
adolescent
pediatric
videoconferencing
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Acceptability and Preferences questionnaire (TAP-Q)
timeFrame: T2 (just after the APA program)
measure: Eating Attitude Test - 26 (EAT-26)
timeFrame: 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:
measure: Hospital Anxiety and Depression (HAD) scale
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Rosenberg Self-esteem Scale (RSS)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Contour Drawing Rating Scale (CDRS)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body Esteem Scale (BES)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Exercise Dependence Scale Revised
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Actimetry
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body Mass Index (BMI)
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body composition - Body cellular mass
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body composition - Fat mass
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body composition - Fat free mass
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body composition - Total body water
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Body composition - Extracellular water
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Isokinetic assessment of upper and lower limbs
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Back extension strength
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Shirado test
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
measure: Sorensen test
timeFrame: Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: Caen Hospital University
name: Fabian GUENOLE, MD PhD Pr
role: PRINCIPAL_INVESTIGATOR
References: