RecruitingNCT06822504

Prevalence of Sarcopenic Obesity in COPD

ESPEN-EASO Sarcopenic Obesity (OS) Diagnostic Criteria Application in a COPD Cohort and OS Correlation to Diaphragmatic Thickness and Mobility for Determination of Tailored Pulmonary Rehabilitation Program: an Observational Study

Sponsor

IRCCS San Raffaele Roma

Enrollment

236 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

COPD Sarcopenic Obesity

Summary

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

Min Age: 40 YearsMax Age: 100 Years

Inclusion Criteria4

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 Criteria14

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.