Study Stopped
Diffiulty in enrolling patients
Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
APANOR
1 other identifier
interventional
9
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2025
CompletedMay 6, 2026
April 1, 2026
4 years
June 25, 2020
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 COMPARATORWith adapted physical activity program (APA)
EXPERIMENTALInterventions
adapted physical activity program (APA)
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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