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Sarcopenia and Nutritional Status in a Rehabilitation Setting

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent from patients or legal guardians for patients unfit to plead

Presence of tracheostomy at admission

Disqualifiers

Refusal

Pregnancy

Pace maker/implantable cardioverter

No legal guardians for patients unfit to plead

Trial population

Patients who underwent tracheostomy before admission, attending a rehabilitation program

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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/Vaccine

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

  • Blood Sample

    Biological/Vaccine

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

  • Anthropometric measures

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with trachestomy7 interventions

Trial outcomes

Primary outcomes

1

Change from admission in muscle mass at decannulation time

Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).

Time frame
Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days
2

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

Time frame
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

Secondary outcomes

1

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

Time frame
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
2

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

Time frame
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
3

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.

Time frame
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days
4

Change from admission in Gut Microbiota (GM) composition at decannulation time

Gut Microbiota (GM) composition

Time frame
Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

University of Florence

Collaborator

Source ClinicalTrials.gov
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