NCT04791540

Sarcopenia and Nutritional Status in a Rehabilitation Setting

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Sarcopenia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-06-09
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-03-10
• Last updated: 2025-08-28

Locations

1 site across 1 country: Italy