Actively Recruiting

Age: 40Years - 100Years
All Genders
ID06822504

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

Age: 40Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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