Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa
CAPANOX
Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility. Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
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
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 16, 2016
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 25, 2018
January 1, 2018
3.1 years
December 5, 2016
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Physical power
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
Day 0
Secondary Outcomes (8)
Pain threshold
Day 0
Wellbeing self-questionnaire
Day 0
Hunger Visual analogical scale
Day 0
PANAS score (self-questionnaire)
Day 0
Hunger Visual analogical scale
Day 0
- +3 more secondary outcomes
Study Arms (3)
Anorexia nervosa
OTHERPatients with DSM-5 criteria of "anorexia nervosa"
First degree relatives
OTHERFirst degree relatives (of patients suffering from anorexia nervosa) with no eating disorder
Controls (with no eating disorder)
OTHEROther
Interventions
Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires
Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
Eligibility Criteria
You may qualify if:
- Patients :
- Woman
- years
- eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder Inventory) and the MINI (Mini International Neuropsychiatric Interview)
- BMI (Body Mass index) between 14 and 17,5
- first degree relative without ED (eating disorders)
- First degree relatives :
- Woman
- years
- Mother or sister of patient with eating disorders
- BMI (Body Mass index) upper to 17,5
- Healthy of all ED (eating disorders)
- Controls :
- Woman
- years
- +2 more criteria
You may not qualify if:
- All groups :
- Contraindication in the practice of an intensive sport
- Cardiovascular Family history with risk of cardiovascular unwanted events
- Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport
- Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute)
- Related and controls :
- Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Sainte Anne
Paris, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Philip GORWOOD, MD, PhD
CHSA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 16, 2016
Study Start
February 27, 2017
Primary Completion
April 1, 2020
Study Completion
September 1, 2020
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share