NCT05770089

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2022Dec 2026

Study Start

First participant enrolled

December 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

December 13, 2022

Last Update Submit

July 22, 2025

Conditions

Keywords

eating disordersanorexia nervosaphysical activityexercisepsychiatrymental healthmuscle strengthchronobiologyphysical conditionadolescentpediatricvideoconferencing

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (18)

  • Hospital Anxiety and Depression (HAD) scale

    Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  • Rosenberg Self-esteem Scale (RSS)

    Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  • Contour Drawing Rating Scale (CDRS)

    Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  • Body Esteem Scale (BES)

    Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  • Exercise Dependence Scale Revised

    Change from T1 (just before the APA program) at T2 (just after the APA program) then T3 (8 weeks after the APA program)

  • +13 more secondary outcomes

Study Arms (2)

AM-APA

EXPERIMENTAL

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

Other: Adapted Physical Activity (APA)

AM-T

NO INTERVENTION

The group without additional intervention other than the outpatient care.

Interventions

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

Also known as: Interventional exercise therapy
AM-APA

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Calvados, 14033, France

Location

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating DisordersMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Fabian GUENOLE, MD PhD Pr

    Caen Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

March 15, 2023

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations