Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness
NCT ID: NCT06894043
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-07-07
2026-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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APA + NC
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.
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.
Control
* 2-week run-in period
* Followed by an 8-week period of conventional management without APA and without NC
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Laboratoire Interuniversitaire de Biologie de la Motricité
OTHER
Target Tape
INDUSTRY
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Locations
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CHU de Saint-Etienne
Saint-Etienne, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANSM
Identifier Type: OTHER
Identifier Source: secondary_id
24CH263
Identifier Type: -
Identifier Source: org_study_id
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