Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD

Phase

N/A

Condition

Sarcopenia

Emphysema

Treatment

Multidisciplinary clinic evaluation

COPD standard of care

Clinical Study ID

NCT07059637

25-857

Ages > 40
All Genders

Study Summary

Sarcopenia, or skeletal muscle loss, impacts up to 40% of COPD patients and is a major cause for morbidity and mortality. Despite the high clinical significance of sarcopenia in COPD, the diagnosis remains elusive because accurate measures of skeletal muscle are not tested during routine clinical care. The goal is to use evidence-based strategies to diagnose and treat sarcopenia due to COPD. The multidisciplinary team includes a pulmonologist, pharmacist, COPD nurse, and COPD coordinator. The investigators anticipate that the approach will improve clinical outcomes for COPD patients with sarcopenia as compared to standard of care visits in ambulatory COPD clinics. The investigators will determine if the approach improves skeletal muscle mass and function, and also improves clinical outcomes related to frequency of hospitalization or ED (Emergency Department) visits, COPD exacerbations, and mortality.

Eligibility Criteria

Inclusion

Inclusion Criteria:

COPD exacerbation as the primary cause for inpatient hospitalization OR secondarydiagnosis of COPD exacerbation with acute respiratory failure as the primarydiagnosis.
Patients must have CT (Computed Tomography) imaging performed during their admissionand evidence of low skeletal muscle mass determined by CT imaging of the pectoralismuscle
Age > 40 years old.
Spirometry diagnosed COPD with FEV1/FVC ratio <0.70 with at least moderateobstruction (FEV1; forced expiratory volume in 1 second <80%).
Patients must have smoked at least 10 pack years and may be current or formersmokers.

Exclusion

Exclusion Criteria:

History of other comorbid lung disease (i.e. interstitial lung disease, asthma).
Currently being evaluated or already listed for lung transplant.
Active malignancy.
Significant comorbid end organ failure defined as congestive heart failure (ejectionfraction<40%), end stage renal disease requiring dialysis, or cirrhosis (based onradiologic imaging).

Study Design

Multidisciplinary clinic evaluation

October 10, 2025

December 01, 2027

Study Description

The goal of this study is to determine whether the multidisciplinary sarcopenia clinic improves outcomes compared to standard of care ambulatory COPD clinics. The proposed study will be a prospective observational study. The investigators will compare the sarcopenia clinic with COPD ambulatory clinics and match based on severity of COPD. With informed consent and approval from Cleveland Clinic's IRB, the investigators will enroll patients with spirometry-confirmed COPD and evidence of sarcopenia who were recently admitted to either main campus Cleveland Clinic or regional facilities for a COPD exacerbation. COPD patients will be seen as a hospital follow up appointment in the multidisciplinary sarcopenia clinic or an outpatient ambulatory COPD clinic. Patients will be followed longitudinally for one year.

Subject Selection:

Recruitment: COPD patients admitted for a COPD exacerbation will be enrolled. Patients who are eligible for the trial will be offered placement in either the multidisciplinary clinic or the standard ambulatory COPD clinics. Our statistical analysis plan will include adjustment for disease severity using regression models, so that the same acuity of disease is being studied across both clinics.

Connect with a study center

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United States
Active - Recruiting

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