Sarcopenia and Nutritional Status in a Rehabilitation Setting
August 21, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus
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.
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chiara F Gheri, MD
- Phone Number: 00390557393612
- Email: cgheri@dongnocchi.it
Study Locations
-
-
Italy
-
Florence, Italy, Italy, 50143
- Recruiting
- Fondazione Don Carlo Gnocchi
-
Contact:
- Chiara F Gheri, MD
- Phone Number: 00390557393612
- Email: cgheri@dongnocchi.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who underwent tracheostomy before admission, attending a rehabilitation program
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with trachestomy
Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation
|
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
A fecal sample obtained at admission (T0) and at decannulation time (T1)
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from admission in muscle mass at decannulation time
Time Frame: Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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 |
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Change from admission in nutritional status at decannulation time
Time Frame: 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. |
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
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Gut Microbiota (GM) composition
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Protein C reactive (PCR)
Time Frame: 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
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Lymphocyte count
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in lymphocyte count at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Creatinine
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in creatinine at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Creatine Poshokinase
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in selenium at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Leptin
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in leptin at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Uric Acid
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in uric acid at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Magnesium
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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)
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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)
Time Frame: 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
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Dehydroepiandrosterone (DHEA)
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Change from admission in dehydroepiandrosterone (DHEA) at decannulation time
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Testosterone
Time Frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
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
Time Frame: 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
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
|
Tumor Necrosis Factor-α (TNF-α)
Time Frame: 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
|
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chiara F Gheri, MD, Fondazione Don Carlo Gnocchi Onlus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Estimated)
August 28, 2025
Last Update Submitted That Met QC Criteria
August 21, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sarcopenia
- Investigative Techniques
- Therapeutics
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Environment and Public Health
- Blood Specimen Collection
- Microbiota
- Microbiological Phenomena
- Biota
- Biodiversity
- Ecosystem
- Environment
- Ecological and Environmental Phenomena
- Biological Phenomena
- Phlebotomy
- Gastrointestinal Microbiome
Other Study ID Numbers
- SARCOBIA1_FDG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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