Actively Recruiting

Age: 40Years - 100Years
All Genders
NCT06822504

Prevalence of Sarcopenic Obesity in COPD

Led by IRCCS San Raffaele Roma · Updated on 2025-02-12

236

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 > 40 years of either sex
  • Body mass index (BMI) above 18.5
  • Stable COPD diagnosis 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 or diastolic > 100 mmHg)
  • Hypotension (systolic < 100 mmHg)
  • Significant comorbidities limiting exercise tolerance
  • Current infectious diseases including HIV
  • Active or recent malignancy within 5 years
  • Severe neurological, rheumatologic, or musculoskeletal diseases
  • History of thoracic surgery
  • Severe aortic stenosis, uncontrolled arrhythmias, recent cardiac ischemic event
  • Cognitive impairments preventing study understanding or compliance
  • Failure to sign informed consent
  • Any serious medical condition affecting safety or rehabilitation course

AI-Screening

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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

CONTACT

F

Franco Pasqua, MD

CONTACT

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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