Clinical trial NCT04791540: Sarcopenia and Nutritional Status in a Rehabilitation Setting
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Keywords: handgrip strenght
bioelectrical impedance analysis (BIA)
respiratory rehabilitation
tracheostomy decannulation
gut microbiota
GLIM criteria
MUST
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Florence
First posted: 2021-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent tracheostomy before admission, attending a rehabilitation program

Brief 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 criteria: Inclusion Criteria:

* Signed informed consent from patients or legal guardians for patients unfit to plead
* Presence of tracheostomy at admission

Exclusion Criteria:

* Refusal
* Pregnancy
* Pace maker/implantable cardioverter
* No legal guardians for patients unfit to plead

Primary outcomes:
measure: Change from admission in muscle mass at decannulation time
timeFrame: Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Change from admission in hangrip strenght at decannulation time
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary outcomes:
measure: Change from admission in Body Mass Index (BMI) score at decannulation time
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Change from admission in nutritional status at decannulation time
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Change from admission in Gut Microbiota (GM) composition at decannulation time
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Protein C reactive (PCR)
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Lymphocyte count
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Creatinine
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Creatine Poshokinase
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Total serum protein
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Albumin
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Vitamin (25OH) D
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Selenium
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Leptin
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Uric Acid
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Magnesium
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Growth Hormone (GH)
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Insuline-like Growth Factor-1 (IGF-1)
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Dehydroepiandrosterone (DHEA)
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Testosterone
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Pro-inflammatory cytokine interleukin IL-6
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
measure: Tumor Necrosis Factor-α (TNF-α)
timeFrame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Chiara F Gheri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee, GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):207-217. doi: 10.1002/jcsm.12383.
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