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NCT Number: NCT04791540

Sarcopenia and Nutritional Status in a Rehabilitation Setting

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

handgrip strenght

Diagnostic 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)

MUST

Diagnostic Test

Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)

GLIM

Diagnostic Test

Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)

gut microbiota

Biological

A fecal sample obtained at admission (T0) and at decannulation time (T1)

Blood sample

Biological

A Blood sample obtained at admission (T0) and at decannulation time (T1)

Anthropometric measures

Other

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

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara F Gheri, MD

CONTACT

[email protected]

00390557393612

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Florence

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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