Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study

Anorexia Nervosa Clinical Trial

— APAREXIM-P  

Official title:

Impact of an Adapted Physical Activity Program Supervised by Videoconference in Patients With Anorexia Nervosa: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05770089
• Other study ID #: 2022-A01245-38
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Exercise Therapy
• Videoconferencing

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)