Prevalence of Sarcopenic Obesity in COPD

NCT06822504 | Recruiting

• 1 other identifier: 135/SR/24
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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

Sarcopenic Obesity; COPD

Keywords

sarcopenic obesity; COPD; diaphragmatic ultrasound

Outcome Measures

Primary Outcomes (1)

• Diagnosis and calculation of sarcopenic obesity in COPD

  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 \> 30 kg/m2 or CV (waist circumference) \> 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

Study Arms (3)

Normal weight

18.5\< BMI \> 24.99

Overweight

25\< BMI \> 29.99

Obese

BMI \> 30

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable COPD admitted to the respiratory rehabilitation ward

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, Roma, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lucia Gatta, PhD

CONTACT

0039 0652253440; lucia.gatta@sanraffaele.it

Franco Pasqua, MD

CONTACT

0039 0652258336; franco.pasqua@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: February 12, 2025
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

IT (1)