Prevalence of Sarcopenic Obesity in COPD (OS-BPCO)

February 6, 2025 updated by: IRCCS San Raffaele Roma

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

From the review of the literature, there is a wide interest on both excess and deficient malnutrition in COPD patients, and more and more interest is being paid to sarcopenic obesity, which is a clinico-functional condition characterized by the coexisting presence of obesity, characterized by excess fat mass (FM), and sarcopenia, defined as reduced muscle mass and reduced function.

In the literature, there is no unambiguity on the diagnosis of sarcopenic obesity in terms of diagnostic criteria and cut-offs. Only recently, in 2022, have criteria for the diagnosis of sarcopenic obesity been defined through ESPEN/EASO consensus [Donini et al, 2022], shared by the international scientific community (Sarcopenic Obesity Global Leadership Initiative (SOGLI)).

The prevalence of sarcopenia in COPD patients is estimated to be 27% (He et al, 2023).Specifically, on the Italian population, at present it is known that the prevalence of sarcopenia in COPD is 24% (De Blasio et al, 2018), and that the prevalence of sarcopenia in obese individuals in the general population is 20 percent (Poggiogalle et al, 2026) but there are no recent studies showing what is the prevalence of sarcopenic obesity (diagnosed with ESPEN/EASO criteria) in COPD subjects in the Italian population.

This study aims to apply ESPEN/EASO criteria to identify obese sarcopenic patients and calculate the prevalence of sarcopenic obesity in COPD patients.

Finally, with this work, the investigators aim to study the impact of sarcopenic obesity on respiratory function (using both spirometric and ultrasonographic parameters to study the diaphragm), performance, degree of dyspnea, and thus quality of life in COPD patients, emphasizing the importance of early diagnosis in individuals with sarcopenic obesity in order to be able to intervene through targeted nutritional strategies to treat patients with chronic conditions, such as COPD, that significantly impact quality of life and health status.

Study Type

Observational

Enrollment (Estimated)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with stable COPD admitted to the respiratory rehabilitation ward

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal weight
18.5< BMI > 24.99
Overweight
25< BMI > 29.99
Obese
BMI > 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis and calculation of sarcopenic obesity in COPD
Time Frame: From enrollment to the end of treatment at 4 weeks

Application of ESPEN/EASO criteria for the diagnosis of sarcopenic obesity and calculation of OS prevalence in a sample of COPD patients.

Sarcopenic obesity (ESPEN/EASO criteria): BMI &gt; 30 kg/m2 or CV (waist circumference) &gt; 102 cm M, 88 cm F E Clinical symptoms or clinical suspicion for OS screening or SARC-F ≥ 4 HGS + Sit-to-Stand test + BIA
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/SR/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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