Actively Recruiting
ESPEN-EASO Sarcopenic Obesity Diagnostic Criteria Application in COPD Patients and Its Relation to Diaphragm Function and Rehabilitation Outcomes: An Observational Study
Led by IRCCS San Raffaele Roma · Updated on 2025-02-12
236
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the prevalence of sarcopenic obesity among patients with chronic obstructive pulmonary disease (COPD) using recently defined ESPEN/EASO diagnostic criteria. Sarcopenic obesity is a condition characterized by excess fat mass and reduced muscle mass and function. The study aims to understand how sarcopenic obesity affects respiratory function, disease severity, exercise performance, quality of life, and dyspnea levels in COPD patients compared to those with normal weight or sarcopenia alone. This observational study involves assessing COPD patients according to their body mass index (BMI) categories: normal weight, overweight, and obese. Patients undergo evaluations including spirometry to measure lung function, ultrasound to assess diaphragm thickness and movement, and the six-minute walk test (6-MWT) to gauge exercise capacity. Questionnaires measuring dyspnea and quality of life are also administered. The study applies the ESPEN/EASO criteria to diagnose sarcopenic obesity and calculate its prevalence within the COPD population. Participants are monitored from enrollment through a 4-week period during which diagnosis and calculation of sarcopenic obesity occur. Researchers collect data on respiratory function, physical performance, dyspnea, and quality of life. The study emphasizes early diagnosis to enable targeted nutritional and rehabilitation strategies. No investigational therapies are administered; this is an observational study focusing on detailed assessments and correlations within the COPD patient group.
CONDITIONS
Brief Title
Prevalence of Sarcopenic Obesity in COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 40 years of any sex
- Body mass index (BMI) above 18.5
- Diagnosis of stable COPD according to GOLD 2021 classification
- Signed informed consent after receiving study information
You will not qualify if you...
- Unstable COPD at enrollment
- Body mass index (BMI) below 18.5
- Presence of tracheostomy
- Uncontrolled hypertension (systolic >160 mmHg, diastolic >100 mmHg)
- Hypotension (systolic <100 mmHg)
- Significant comorbidities limiting exercise tolerance
- Active infectious diseases including HIV
- Malignancy ongoing or in remission less than 5 years
- Severe neurological, rheumatologic, or musculoskeletal diseases
- History of thoracic surgery
- Severe aortic stenosis, uncontrolled arrhythmias, recent cardiac ischemic event
- Cognitive impairments preventing understanding or compliance
- Failure to sign informed consent
- Any serious medical condition interfering with safety or rehabilitation course
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo assessment to diagnose sarcopenic obesity using ESPEN/EASO criteria and evaluate respiratory and diaphragm function.
1 to 2 visits depending on assessments
Duration - Up to several months depending on individual patient follow-up
Participants are observed to study the impact of sarcopenic obesity on respiratory function, performance, dyspnea, and quality of life.
Additional visits may occur depending on clinical follow-up
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Roma, Roma, Italy
Actively Recruiting
Research Team
L
Lucia Gatta, PhD
F
Franco Pasqua, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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