Sarcopenia and Nutritional Status in a Rehabilitation Setting

Sarcopenia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791540
• Other study ID #: SARCOBIA1_FDG
• Status: Recruiting
• Start date: June 9, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Chiara F Gheri, MD
• Phone: 00390557393612
• Email: cgheri[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Diagnostic Test:
• handgrip strenght
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
• Bioelectrical Impedance Analysis (BIA)
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
• MUST
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
• GLIM
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)

Biological:
• Gut microbiota
A fecal sample obtained at admission (T0) and at decannulation time (T1)
• Blood Sample
A Blood sample obtained at admission (T0) and at decannulation time (T1)

Other:
• Anthropometric measures
Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi	Firenze

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available. — View Citation

Kutsukutsa J, Mashamba-Thompson TP, Saman Y. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol. Syst Rev. 2017 Dec 4;6(1):239. doi: 10.1186/s13643-017-0634-0. — View Citation

Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012. — View Citation

Prado CM, Purcell SA, Alish C, Pereira SL, Deutz NE, Heyland DK, Goodpaster BH, Tappenden KA, Heymsfield SB. Implications of low muscle mass across the continuum of care: a narrative review. Ann Med. 2018 Dec;50(8):675-693. doi: 10.1080/07853890.2018.1511918. Epub 2018 Sep 12. — View Citation

Ticinesi A, Nouvenne A, Cerundolo N, Catania P, Prati B, Tana C, Meschi T. Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia. Nutrients. 2019 Jul 17;11(7):1633. doi: 10.3390/nu11071633. — View Citation

Toptas M, Yalcin M, Akkoc I, Demir E, Metin C, Savas Y, Kalyoncuoglu M, Can MM. The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit. Biomed Res Int. 2018 Feb 12;2018:5263208. doi: 10.1155/2018/5263208. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Creatinine	Change from admission in creatinine at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	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
Secondary	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
Secondary	Albumin	Change from admission in albumin at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	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
Secondary	Selenium	Change from admission in selenium at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	Leptin	Change from admission in leptin at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	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
Secondary	Magnesium	Change from admission in magnesium at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Testosterone	Change from admission in testosterone at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary	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
Secondary	Tumor Necrosis Factor-a (TNF-a)	Change from admission in Tumor Necrosis Factor-a (TNF-a) at decannulation time	Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days