Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Lean body mass
研究概览
简要总结
Constitutional Thinness (CT) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. The clinical consequences are numerous and the pathophysiology remains poorly understood.
Currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness.
Our hypothesis is that an adapted physical activity program (APA) combined with compensatory nutrition (CN) could help these patients gain lean mass (muscle mass).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Gender: Female
- •BMI: ≤ 18.5 kg/m²
- •Weight Stability: Stable weight for at least 3 months
- •Age: 18 to 50 years old at the inclusion visit
- •Diagnosed with Constitutional thinness
排除标准
- •Pregnancy, Parturition, or Lactation
- •Legal Restrictions: Individuals deprived of liberty, involuntarily hospitalized, or hospitalized for reasons other than research purposes, adults under legal protection (guardianship or curatorship) or unable to provide consent
- •Eating Disorders: Individuals with eating disorders (DSM IV and 5 criteria)
- •Excessive Alcohol Consumption: Consumption exceeding the equivalent of 10 glasses of wine per week
- •Severe Progressive Conditions: Progressive severe conditions (e.g., diabetes)
- •Intense Physical Activity: Individuals engaging in intense physical activity (> 3 sessions per week)
- •Heavy Smoking: Significant smoking (>10 cigarettes per day)
- •Psychiatric Conditions: Presence of depressive or psychiatric conditions requiring antidepressant or psychotropic treatment
- •Medical or Surgical History: Medical or surgical history deemed incompatible with the study by the investigator
- •MRI Contraindication: Individuals with contraindications to MRI will not undergo spectro-MRI analyses
研究组 & 干预措施
APA + NC
干预措施: Adapted Physical Activity (APA) (Other)
APA + NC
干预措施: Compensatory Nutrition (NC) (Behavioral)
Control
- 2-week run-in period
- Followed by an 8-week period of conventional management without APA and without NC
结局指标
主要结局
Lean body mass
时间窗: From day 1 to week 8
Lean body mass gain (kg) measured by bioimpedance
次要结局
- BMI(From day 1 to week 8)
- Physical exercise capacity(From day 1 to week 8)
- Energy balance(From day 1 to week 8)
- Quality of life SF-12 questionnaire(From day 1 to week 8)