Understanding Sarcopenic Obesity in COPD Patients
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
This study is trying to see how common sarcopenic obesity is in people with COPD and how it affects their breathing, disease severity, and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 236 (estimated) |
| Ages | 40 Years to 100 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT06822504 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients over 40 years old with a stable diagnosis of COPD and a BMI greater than 18.5.
Not a fit: Patients with unstable COPD, significant comorbidities, or those with a BMI less than 18.5 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and management strategies for COPD patients suffering from sarcopenic obesity.
How similar studies have performed: While there is growing interest in sarcopenic obesity, this specific application of the ESPEN/EASO criteria in COPD patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Roma, Roma
- IRCCS San Raffaele — Roma, Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Lucia Gatta, PhD
- Email: lucia.gatta@sanraffaele.it
- Phone: 0039 0652253440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.