Sarcopenia and Nutritional Status in a Rehabilitation Setting

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sarcopenia

Intervention / Treatment
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* Diagnostic Test: handgrip strenght
* Diagnostic Test: Bioelectrical Impedance Analysis (BIA)
* Diagnostic Test: MUST
* Diagnostic Test: GLIM
* Biological: Gut microbiota
* Biological: Blood Sample
* Other: Anthropometric measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with trachestomy<br>Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation | Diagnostic Test: handgrip strenght<br>* Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)<br>Diagnostic Test: Bioelectrical Impedance Analysis (BIA)<br>* Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)<br>Diagnostic Test: MUST<br>* Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)<br>Diagnostic Test: GLIM<br>* Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)<br>Biological: Gut microbiota<br>* A fecal sample obtained at admission (T0) and at decannulation time (T1)<br>Biological: Blood Sample<br>* A Blood sample obtained at admission (T0) and at decannulation time (T1)<br>Other: Anthropometric measures<br>* Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from admission in Body Mass Index (BMI) score at decannulation time | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time | 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 | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Change from admission in nutritional status at decannulation time | 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. | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Change from admission in Gut Microbiota (GM) composition at decannulation time | Gut Microbiota (GM) composition | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Protein C reactive (PCR) | Change from admission in Protein C reactive (PCR) at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Lymphocyte count | Change from admission in lymphocyte count at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Creatinine | Change from admission in creatinine at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Creatine Poshokinase | Change from admission in creatine poshokinase at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Total serum protein | Change from admission in total serum protein at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Albumin | Change from admission in albumin at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Vitamin (25OH) D | Change from admission in vitamin (25OH) D at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Selenium | Change from admission in selenium at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Leptin | Change from admission in leptin at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Uric Acid | Change from admission in uric acid at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Magnesium | Change from admission in magnesium at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Growth Hormone (GH) | Change from admission in growth hormone at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Insuline-like Growth Factor-1 (IGF-1) | Change from admission in Insuline-like Growth Factor-1 (IGF-1) at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Dehydroepiandrosterone (DHEA) | Change from admission in dehydroepiandrosterone (DHEA) at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Testosterone | Change from admission in testosterone at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Pro-inflammatory cytokine interleukin IL-6 | Change from admission in pro-inflammatory cytokine interleukinIL-6 at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 
| Tumor Necrosis Factor-α (TNF-α) | Change from admission in Tumor Necrosis Factor-α (TNF-α) at decannulation time | Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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handgrip strenght, bioelectrical impedance analysis (BIA), respiratory rehabilitation, tracheostomy decannulation, gut microbiota, GLIM criteria, MUST