Sarcopenia
Conditions
Keywords
handgrip strenght, bioelectrical impedance analysis (BIA), respiratory rehabilitation, tracheostomy decannulation, gut microbiota, GLIM criteria, MUST
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.
Interventions
DIAGNOSTIC_TESThandgrip strenght
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
DIAGNOSTIC_TESTBioelectrical Impedance Analysis (BIA)
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
DIAGNOSTIC_TESTMUST
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
DIAGNOSTIC_TESTGLIM
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
BIOLOGICALGut microbiota
A fecal sample obtained at admission (T0) and at decannulation time (T1)
BIOLOGICALBlood Sample
A Blood sample obtained at admission (T0) and at decannulation time (T1)
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
University of Florence
Fondazione Don Carlo Gnocchi Onlus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from admission in Body Mass Index (BMI) score at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Measurement of height and weight to get a BMI score (weight/(height\^2). BMI \<18.5 Kg/m\^2: underweight BMI 18.5-24.9 Kg/m\^2: normal range BMI 25.0-29.9 Kg/m\^2: overweight BMI 30.0-34.9 Kg/m\^2 obese class I BMI 35.0-39.9 Kg/m\^2 obese class II BMI \>= 40 Kg/m\^2 obese class III |
| Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | MUST is a screening tool to identify adults who are malnourished, at risk of malnutrition or obese. score 0: low risk score 1: medium risk score 2 or more: high risk |
| Change from admission in nutritional status at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Global Leadership Initiative on Malnutrition (GLIM) criteria are 5 diagnostic criteria to assess malnutrition that include 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation/disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present. |
| Change from admission in Gut Microbiota (GM) composition at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Gut Microbiota (GM) composition |
| Protein C reactive (PCR) | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in Protein C reactive (PCR) at decannulation time |
| Lymphocyte count | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in lymphocyte count at decannulation time |
| Creatinine | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in creatinine at decannulation time |
| Creatine Poshokinase | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in creatine poshokinase at decannulation time |
| Total serum protein | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in total serum protein at decannulation time |
| Albumin | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in albumin at decannulation time |
| Vitamin (25OH) D | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in vitamin (25OH) D at decannulation time |
| Selenium | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in selenium at decannulation time |
| Leptin | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in leptin at decannulation time |
| Uric Acid | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in uric acid at decannulation time |
| Magnesium | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in magnesium at decannulation time |
| Growth Hormone (GH) | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in growth hormone at decannulation time |
| Insuline-like Growth Factor-1 (IGF-1) | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in Insuline-like Growth Factor-1 (IGF-1) at decannulation time |
| Dehydroepiandrosterone (DHEA) | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in dehydroepiandrosterone (DHEA) at decannulation time |
| Testosterone | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in testosterone at decannulation time |
| Pro-inflammatory cytokine interleukin IL-6 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in pro-inflammatory cytokine interleukinIL-6 at decannulation time |
| Tumor Necrosis Factor-α (TNF-α) | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | Change from admission in Tumor Necrosis Factor-α (TNF-α) at decannulation time |
Countries
Italy
Contacts
Primary ContactChiara F Gheri, MD
Outcome results
None listed