NCT06822504Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 236 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- IRCCS San Raffaele Roma
- NCT number
- NCT06822504
What you commit to
- Study type: Observational
- Planned participants: 236
- From 1 Jun 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- uncontrolled hypertension (systolic blood pressure \> 160 mmHg, diastolic \> 100 mmHg);
- 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.
Other
- COPD not stabilized at the time of enrollment;
- BMI \< 18.5
- presence of tracheostomy
- hypotension (systolic blood pressure \<100 mm Hg);
- Significant comorbidities that limit exercise tolerance;
Who the study is looking for
- 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.
Age in the registry: 40 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.