Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
Recruiting · NCT07059637 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- COPD exacerbation as the primary cause for inpatient hospitalization OR secondary diagnosis of COPD exacerbation with acute respiratory failure as the primary diagnosis.
- Patients must have CT (Computed Tomography) imaging performed during their admission and evidence of low skeletal muscle mass determined by CT imaging of the pectoralis muscle
- Age \> 40 years old.
- Spirometry diagnosed COPD with FEV1/FVC ratio \<0.70 with at least moderate obstruction (FEV1; forced expiratory volume in 1 second \<80%).
- Patients must have smoked at least 10 pack years and may be current or former smokers.
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 (ejection fraction\<40%), end stage renal disease requiring dialysis, or cirrhosis (based on radiologic imaging).
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic Foundation - Cleveland, Ohio, United States