NCT04791540RECRUITINGN/A

Sarcopenia and Nutritional Status in a Rehabilitation Setting

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.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

30 participants

Sites

1 locations

Start Date

June 2021

Completion

December 2025

Sarcopeniahandgrip strenghtBioelectrical Impedance Analysis (BIA)MUST

View on ClinicalTrials.gov

Primary Outcomes

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

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community.

Cederholm T, Jensen G L, Correia M I T D et al.Journal of cachexia, sarcopenia and muscle2020

DOI PubMed

Sarcopenia: revised European consensus on definition and diagnosis.

Cruz-Jentoft Alfonso J, Bahat Gϋlistan, Bauer Jϋrgen et al.Age and ageing2019

DOI PubMed

Bioelectrical impedance analysis-part II: utilization in clinical practice.

Kyle Ursula G, Bosaeus Ingvar, De Lorenzo Antonio D et al.Clinical nutrition (Edinburgh, Scotland)2005

DOI PubMed

Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol.

Kutsukutsa John, Mashamba-Thompson Tivani Phosa, Saman YouganSystematic reviews2018

DOI PubMed

Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia.

Ticinesi Andrea, Nouvenne Antonio, Cerundolo Nicoletta et al.Nutrients2020

DOI PubMed

The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit.

Toptas Mehmet, Yalcin Mazhar, Akkoc İbrahim et al.BioMed research international2018

DOI PubMed

Implications of low muscle mass across the continuum of care: a narrative review.

Prado Carla M, Purcell Sarah A, Alish Carolyn et al.Annals of medicine2019

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Fetching protocol from ClinicalTrials.gov…

NCT04791540RECRUITINGN/A

Sarcopenia and Nutritional Status in a Rehabilitation Setting

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

30 participants

Sites

1 locations

Start Date

June 2021

Completion

December 2025

Sarcopeniahandgrip strenghtBioelectrical Impedance Analysis (BIA)MUST

View on ClinicalTrials.gov

Primary Outcomes

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

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community.

Cederholm T, Jensen G L, Correia M I T D et al.Journal of cachexia, sarcopenia and muscle2020

DOI PubMed

Sarcopenia: revised European consensus on definition and diagnosis.

Cruz-Jentoft Alfonso J, Bahat Gϋlistan, Bauer Jϋrgen et al.Age and ageing2019

DOI PubMed

Bioelectrical impedance analysis-part II: utilization in clinical practice.

Kyle Ursula G, Bosaeus Ingvar, De Lorenzo Antonio D et al.Clinical nutrition (Edinburgh, Scotland)2005

DOI PubMed

Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol.

Kutsukutsa John, Mashamba-Thompson Tivani Phosa, Saman YouganSystematic reviews2018

DOI PubMed

Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia.

Ticinesi Andrea, Nouvenne Antonio, Cerundolo Nicoletta et al.Nutrients2020

DOI PubMed

The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit.

Toptas Mehmet, Yalcin Mazhar, Akkoc İbrahim et al.BioMed research international2018

DOI PubMed

Implications of low muscle mass across the continuum of care: a narrative review.

Prado Carla M, Purcell Sarah A, Alish Carolyn et al.Annals of medicine2019

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Sarcopenia and Nutritional Status in a Rehabilitation Setting

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Sarcopenia and Nutritional Status in a Rehabilitation Setting

Primary Outcomes

Eligibility

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Trial Sites (1)