Sarcopenia and Nutritional Status in a Rehabilitation Setting

Recruiting

• Conditions: Sarcopenia
• Interventions: 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

• Registration Number: NCT04791540
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-06-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with trachestomy	handgrip strenght	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	Bioelectrical Impedance Analysis (BIA)	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	GLIM	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	Gut microbiota	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	Anthropometric measures	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	MUST	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
Patients with trachestomy	Blood Sample	Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Creatinine	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days	Change from admission in creatinine 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
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
Leptin	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days	Change from admission in leptin 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
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
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.
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
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
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
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 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
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

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Firenze, Italy