Sarcopenia and Nutritional Status in a Rehabilitation Setting

Condition(s) studied

Investigational drug(s) / intervention(s)

handgrip strenght: Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)

Bioelectrical Impedance Analysis (BIA): Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)

MUST: Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)

GLIM: Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)

Gut microbiota: A fecal sample obtained at admission (T0) and at decannulation time (T1)

Blood Sample: A Blood sample obtained at admission (T0) and at decannulation time (T1)

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)

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.

Eligibility

Primary outcome measure(s)

• Change from admission in muscle mass at decannulation time — Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
  Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).
• Change from admission in hangrip strenght at decannulation time — Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
  Measurement of handgrip strenght with a handheld dynamometer. Male cut-off: \<27 Kg Female cut-off: \<16 Kg

Trial sites (1)

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