Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted Physical Activity (APA), Compensatory Nutrition (NC).
- Who it may be relevant to
- Registry conditions: Constitutional Thinness. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Other Adapted Physical Activity (APA)
The APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks. - Behavioral Compensatory Nutrition (NC)
The Compensatory Nutrition (NC) intervention will consist of a 2-week running-in period, followed by a period of compensated nutrition (NC) for 8 weeks.
Primary outcome measures
- Lean body mass [Time frame: From day 1 to week 8]
Secondary outcome measures (4)
- BMI [Time frame: From day 1 to week 8]
- Energy balance [Time frame: From day 1 to week 8]
- Physical exercise capacity [Time frame: From day 1 to week 8]
- Quality of life SF-12 questionnaire [Time frame: From day 1 to week 8]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT06894043 · 24CH263 · ANSM