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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2025-A00088-41 |
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| Name | Class |
|---|---|
| Laboratoire Interuniversitaire de Biologie de la Motricité | OTHER |
| Target Tape | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APA + NC | Experimental |
| |
| Control | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Physical Activity (APA) | Other | The APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lean body mass | Lean body mass gain (kg) measured by bioimpedance | From day 1 to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Body masse index : ratio between weight and height | From day 1 to week 8 |
| Energy balance | Ratio between calorie intake and calorie expenditure Caloric intake measured by dietary records over 2 weeks (calorie); Calorie expenditure: Resting metabolism measured by indirect calorimetry (kcal/24h); + Postprandial thermogenesis measured by indirect calorimetry (kcal/24h);; + Physical activity energy expenditure measured by connected watch (kcal/24h); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natacha GERMAIN, PhD | Contact | (0)477120621 | +33 | natacha.germain@chu-st-etienne.fr |
| Florence RANCON, Cheffe de projet | Contact | (0) 477829458 | +33 | florence.rancon@chu-st-etienne.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | France | 42055 | France |
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| Compensatory Nutrition (NC) | Behavioral | 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. |
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| From day 1 to week 8 |
| Physical exercise capacity | Changes in VO2max | From day 1 to week 8 |
| Quality of life SF-12 questionnaire | SF-12 questionnaire; Self-measurement questionnaire SF-12 (Short Form Health Survey 12); comprising 12 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite); | From day 1 to week 8 |