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RECRUITING
NCT04791540

Sarcopenia and Nutritional Status in a Rehabilitation Setting

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

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.

Official title: Observational Pilot Study in Patients Who Underwent Tracheostomy: Sarcopenia Assessment by Handgrip Strenght and BIA. Association to Malnutrion Risk, Nutritional Status, Gut Microbioma and Decannulation Time.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2021-06-09

Completion Date

2025-12-31

Last Updated

2025-08-28

Healthy Volunteers

No

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)

Locations (1)

Fondazione Don Carlo Gnocchi

Florence, Italy, Italy