Understanding Sarcopenic Obesity in COPD Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to apply the ESPEN/EASO criteria to diagnose sarcopenic obesity and determine its prevalence among patients with Chronic Obstructive Pulmonary Disease (COPD). It will evaluate the impact of sarcopenic obesity on respiratory function, severity of the disease, and overall quality of life through various assessments including spirometry, ultrasound, and the six-minute walk test. By comparing these patients with normal-weight individuals, the study seeks to clarify the clinical implications of sarcopenic obesity in COPD. The findings could help refine diagnostic criteria and improve patient management.

Why it matters

Who can join: the full rules

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's running

• IRCCS San Raffaele
  Roma, Roma, Italy Recruiting

Study contacts

• Study coordinator: Lucia Gatta, PhD
• Email: lucia.gatta@sanraffaele.it
• Phone: 0039 0652253440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.