Sarcopenia and Nutritional Status in a Rehabilitation Setting
NCT04791540 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-08-28
Summary
In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy.
Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
handgrip strenght
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
- DIAGNOSTIC_TEST
-
Bioelectrical Impedance Analysis (BIA)
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
- DIAGNOSTIC_TEST
-
MUST
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
- DIAGNOSTIC_TEST
-
GLIM
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
- BIOLOGICAL
-
Gut microbiota
A fecal sample obtained at admission (T0) and at decannulation time (T1)
- BIOLOGICAL
-
Blood Sample
A Blood sample obtained at admission (T0) and at decannulation time (T1)
- OTHER
-
Anthropometric measures
Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)
Sponsors & Collaborators
-
University of Florence
collaborator OTHER -
Fondazione Don Carlo Gnocchi Onlus
lead OTHER
Principal Investigators
-
Chiara F Gheri, MD · Fondazione Don Carlo Gnocchi Onlus
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-09
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Italy
Study Locations
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