NCT04817436

Brief Summary

Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 8, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

June 25, 2020

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism

    Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)

    3 months

Secondary Outcomes (5)

  • To evaluate the effects of adapated physical activity program on anthropometric data.

    3 months

  • To evaluate the involving of gut microbiota composition and diversity

    3 months

  • To evaluate the effects of adapated physical activity program on quality of life

    3 months

  • To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation

    3 months

  • To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)

    3 months

Study Arms (2)

Without adapted physical activity program (APA)

ACTIVE COMPARATOR
Other: physical activity program (APA)

With adapted physical activity program (APA)

EXPERIMENTAL
Other: physical activity program (APA)

Interventions

adapted physical activity program (APA)

With adapted physical activity program (APA)Without adapted physical activity program (APA)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Patient \> 18 years
  • Follow-up in the department of clinical Nutrition of Rouen
  • BMI ≥15,0 and \<18,5 kg/m²
  • Diagnosis of anorexia nervosa according to DSM-V classification

You may not qualify if:

  • Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
  • Patients with poor understanding of spoken or written French
  • Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
  • Person subject to a safeguard of justice, guardianship or curatorship.
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

June 25, 2020

First Posted

March 26, 2021

Study Start

September 8, 2021

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations