Prevalence of Sarcopenic Obesity in COPD
Recruiting · NCT06822504 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele Roma
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- COPD not stabilized at the time of enrollment;
- BMI \< 18.5
- presence of tracheostomy
- uncontrolled hypertension (systolic blood pressure \> 160 mmHg, diastolic \> 100 mmHg);
- hypotension (systolic blood pressure \<100 mm Hg);
- Significant comorbidities that limit exercise tolerance;
- intercurrent infectious diseases, including HIV diagnosis;
- Patients diagnosed with malignancy in progress or in remission for less than 5 years;
- patients diagnosed with severe neurological, rheumatologic, or musculoskeletal diseases;
- patients with a history of thoracic surgery;
- presence of severe aortic stenosis, uncontrolled atrial/ventricular arrhythmia, recent cardiac ischemic event;
- cognitive impairment conditions that prevent full understanding of the study protocol (mental retardation, dementia, etc.) and/or adequate test performance compliance;
- failure to sign informed consent;
- any other serious medical condition that may interfere with data interpretation and safety or that may make the respiratory rehabilitation course difficult, limited, or uncomfortable.
Where it is running
1 location listed.
- IRCCS San Raffaele - Roma, Roma, Italy