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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Physical power
研究概览
简要总结
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.
详细描述
This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no eating disorder) and first degree relatives (with no eating disorder) will be tested for emotional accuracy (seing faces on a screen with different core emotions), pain threshold (how long they can support a cold probe), body size (how they see themselves), appetite and cognitive flexibility (a test where the capacity to change rules during a game is done easily or not).
Then all subjects will do a standardized physical exercise which represents an effort with the equivalent level of energy for each participants as being chosen according to each level of competency (assessed through the "maximal aerobic power").
The third step consists in the repetition of (nearly) initial tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 - 50 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 :
- •18 - 50 years
- •Mother or sister of patient with eating disorders
- •BMI (Body Mass index) upper to 17,5
- •Healthy of all ED (eating disorders)
- •18 - 50 years
- •BMI > 17,5
- •Without ED (eating disorders)
排除标准
- •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
研究组 & 干预措施
Anorexia nervosa
Patients with DSM-5 criteria of "anorexia nervosa"
干预措施: Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires (Other)
First degree relatives
First degree relatives (of patients suffering from anorexia nervosa) with no eating disorder
干预措施: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires (Other)
Controls (with no eating disorder)
Other
干预措施: Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires (Other)
结局指标
主要结局
Physical power
时间窗: Day 0
Comparison inter and intra individual of the subjective and objective power to the subjects during a typical physical bike test.
次要结局
- Genetical analysis(Day 0)
- Hunger Visual analogical scale(Day 0)
- Performance on the Briton cognitive test (number of errors)(Day 0)
- Performance on cognitive tests (speed, number of errors), before versus after the exercise, in the three groups.(Day 0)
- Pain threshold(Day 0)
- Wellbeing self-questionnaire(Day 0)
- PANAS score (self-questionnaire)(Day 0)