Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study

NCT ID: NCT05770089

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2026-12-01

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.

Conditions

Anorexia Nervosa; Exercise Therapy; Videoconferencing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

AM-APA

The group following the Adapted Physical Activity program via videoconferencing in addition to the outpatient care.

Group Type: EXPERIMENTAL

Adapted Physical Activity (APA)

Intervention Type: OTHER

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

AM-T

The group without additional intervention other than the outpatient care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adapted Physical Activity (APA)

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

Intervention Type: OTHER

Other Intervention Names

Interventional exercise therapy

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabian GUENOLE, MD PhD Pr

Role: PRINCIPAL_INVESTIGATOR

Caen Hospital University

Locations

Caen University Hospital

Caen, Calvados, France

Countries

France

Other Identifiers

2022-A01245-38

Identifier Type: -

Identifier Source: org_study_id