SarcopeniaNCT04791540
Sarcopenia and Nutritional Status in a Rehabilitation Setting
An observational study of Sarcopenia, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- handgrip strenght, Bioelectrical Impedance Analysis (BIA) and MUST
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent tracheostomy before admission, attending a rehabilitation program
Who may be able to join
- Signed informed consent from patients or legal guardians for patients unfit to plead
- Presence of tracheostomy at admission
Who cannot join
- Refusal
- Pregnancy
- Pace maker/implantable cardioverter
- No legal guardians for patients unfit to plead
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi
Florence, Italy, 50143
Chiara F Gheri, MD, 00390557393612, cgheri@dongnocchi.it
About this study
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.
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.
- Conditions
- Sarcopenia
- Being tested
- handgrip strenght, Bioelectrical Impedance Analysis (BIA), MUST, GLIM, Gut microbiota
- Keywords
- handgrip strenght, bioelectrical impedance analysis (BIA), respiratory rehabilitation, tracheostomy decannulation, gut microbiota, GLIM criteria, MUST
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handgrip strenghtDiagnostic test
Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
Bioelectrical Impedance Analysis (BIA)Diagnostic test
Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
MUSTDiagnostic test
Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
GLIMDiagnostic test
Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
Gut microbiotaBiological
A fecal sample obtained at admission (T0) and at decannulation time (T1)
Blood SampleBiological
A Blood sample obtained at admission (T0) and at decannulation time (T1)
Anthropometric measuresOther
Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)
| Study group | Role | What they receive |
|---|---|---|
| Patients with trachestomy | Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from admission in muscle mass at decannulation time
Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Secondary outcomes (21)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Creatinine
Change from admission in creatinine at decannulation time
Measured: 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
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Albumin
Change from admission in albumin at decannulation time
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Selenium
Change from admission in selenium at decannulation time
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Leptin
Change from admission in leptin at decannulation time
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Magnesium
Change from admission in magnesium at decannulation time
Measured: 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
Measured: 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
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Testosterone
Change from admission in testosterone at decannulation time
Measured: 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
Measured: 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
Measured: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start9 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Sponsor
- Investigators
- Chiara F Gheri, MD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791540
- Sponsor's protocol ID
- SARCOBIA1_FDG
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30920778Cruz-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.
PubMed 31081853Kyle 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.
PubMed 15556267Kutsukutsa 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.
PubMed 29202866Ticinesi 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.
PubMed 31319564Toptas 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.
PubMed 29789798Prado 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.
PubMed 30169116
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04791540
- Acronym / sponsor ID
- SARCOBIA1_FDG
- Conditions
- Sarcopenia
- Keywords
- handgrip strenght, bioelectrical impedance analysis (BIA), respiratory rehabilitation, tracheostomy decannulation, gut microbiota, GLIM criteria, MUST
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with trachestomy | – | Diagnostic Test: handgrip strenght, Diagnostic Test: Bioelectrical Impedance Analysis (BIA), Diagnostic Test: MUST, Diagnostic Test: GLIM, Biological: Gut microbiota, Biological: Blood Sample, Other: Anthropometric measuresPatients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent tracheostomy before admission, attending a rehabilitation program
Key inclusion criteria (2 listed)
- Signed informed consent from patients or legal guardians for patients unfit to plead
- Presence of tracheostomy at admission
Key exclusion criteria (4 listed)
- Refusal
- Pregnancy
- Pace maker/implantable cardioverter
- No legal guardians for patients unfit to plead
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handgrip strenghtMuscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1) | Diagnostic test | Patients with trachestomy |
| Bioelectrical Impedance Analysis (BIA)Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1) | Diagnostic test | Patients with trachestomy |
| MUSTMalnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1) | Diagnostic test | Patients with trachestomy |
| GLIMMalnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1) | Diagnostic test | Patients with trachestomy |
| Gut microbiotaA fecal sample obtained at admission (T0) and at decannulation time (T1) | Biological | Patients with trachestomy |
| Blood SampleA Blood sample obtained at admission (T0) and at decannulation time (T1) | Biological | Patients with trachestomy |
| Anthropometric measuresMeasurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1) | Other | Patients with trachestomy |
Primary outcome
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).
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
21 secondary outcomes
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
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
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
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
Protein C reactive (PCR)
Time frame: 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
Creatinine
Time frame: 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
Total serum protein
Time frame: 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
Vitamin (25OH) D
Time frame: 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
Leptin
Time frame: 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
Magnesium
Time frame: 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
Insuline-like Growth Factor-1 (IGF-1)
Time frame: 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
Testosterone
Time frame: 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
Tumor Necrosis Factor-α (TNF-α)
Time frame: Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 30920778Cederholm 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.
- Background: PubMed 31081853Cruz-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.
- Background: PubMed 15556267Kyle 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.
- Background: PubMed 29202866Kutsukutsa 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.
- Background: PubMed 31319564Ticinesi 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.
- Background: PubMed 29789798Toptas 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.
- Background: PubMed 30169116Prado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiara F Gheri, MD principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara F Gheri, MD (00390557393612, cgheri@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791540, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.