Prevalence of Sarcopenic Obesity in COPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-100
SponsorIRCCS San Raffaele Roma
About this trial
The goal of this observational study is to the purpose is to apply of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.
In addition, this study want to evaluate the impact of sarcopenic obesity on the respiratory function of COPD patients and the degree of severity of respiratory disease, assessed by spirometric examination; diaphragm thickness and excursion, by ultrasonographic study; performance, assessed by six-minute walk test (6-MWT); quality of life and degree of dyspnea (mMRC, Barthel dyspnea, S. George Respiratory Questionnaire); compliance and outcomes at the end of the respiratory rehabilitation course. Comparison with normal-weight patients with and without sarcopenia will help to better understand the clinical impact of sarcopenic obesity in this category of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged > 40 years of either sex;
BMI >18.5
COPD diagnosis according to the GOLD [2021 Global initiative for chronic obstructive lung disease] classification in the stable stage;
Signing of informed consent after receiving all information about the study.
Disqualifiers
COPD not stabilized at the time of enrollment;
BMI < 18.5
presence of tracheostomy
uncontrolled hypertension (systolic blood pressure > 160 mmHg, diastolic > 100 mmHg);
Trial population
Patients with stable COPD admitted to the respiratory rehabilitation ward
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
236 Participants
are grouped into 3 trial groupsGroup A: Normal weight
Group B: Overweight
Group C: Obese
Trial outcomes
Primary outcomes
1
Diagnosis and calculation of sarcopenic obesity in COPD
Application of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients. Sarcopenic obesity (ESPEN/EASO criteria): BMI \&amp;amp;gt; 30 kg/m2 or CV (waist circumference) \&amp;amp;gt; 102 cm M, 88 cm F E Clinical symptoms or clinical suspicion for OS screening or SARC-F ≥ 4 HGS + Sit-to-Stand test + BIA
Time frame
From enrollment to the end of treatment at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov