Sarcopenia and Nutritional Status in a Rehabilitation Setting

NCT04791540 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-08-28

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791540 on ClinicalTrials.gov