Multidisciplinary sarcopenia clinic to diagnose and treat muscle loss from COPD

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

This project will try a multidisciplinary sarcopenia clinic to see if it improves muscle mass, function, and overall health for COPD patients with CT-confirmed muscle loss after a hospitalization.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT07059637 on ClinicalTrials.gov

What this trial studies

The Cleveland Clinic will conduct a prospective observational comparison of a multidisciplinary sarcopenia clinic versus standard ambulatory COPD clinics. Patients hospitalized for a COPD exacerbation with spirometry-confirmed COPD and CT evidence of low pectoralis muscle mass will be enrolled and matched by disease severity. A team including a pulmonologist, pharmacist, COPD nurse, and COPD coordinator will deliver evidence-based diagnostics and treatments targeting skeletal muscle loss. Participants will be followed for one year to compare changes in muscle mass and function, COPD exacerbations, hospital/ED visits, and mortality.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 with spirometry-confirmed COPD (FEV1/FVC <0.70 and FEV1 <80%), at least a 10 pack-year smoking history, CT evidence of low pectoralis muscle mass, and a recent hospitalization for a COPD exacerbation.

Not a fit: Patients without CT-defined sarcopenia or with other major lung diseases, active malignancy, advanced end-organ failure, or listed for lung transplant are unlikely to be eligible or to benefit from this clinic model.

Why it matters

Potential benefit: If successful, the clinic could increase skeletal muscle mass and strength in COPD patients and lower rates of exacerbations and hospital visits.

How similar studies have performed: Exercise, nutrition, and multimodal interventions have improved muscle outcomes in COPD populations, but implementing a dedicated multidisciplinary sarcopenia clinic is relatively novel and not widely tested.

Eligibility criteria

Inclusion Criteria:

1. COPD exacerbation as the primary cause for inpatient hospitalization OR secondary diagnosis of COPD exacerbation with acute respiratory failure as the primary diagnosis.
2. 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
3. Age \> 40 years old.
4. Spirometry diagnosed COPD with FEV1/FVC ratio \<0.70 with at least moderate obstruction (FEV1; forced expiratory volume in 1 second \<80%).
5. Patients must have smoked at least 10 pack years and may be current or former smokers.

Exclusion Criteria:

1. History of other comorbid lung disease (i.e. interstitial lung disease, asthma).
2. Currently being evaluated or already listed for lung transplant.
3. Active malignancy.
4. 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 this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Amy Attaway, MD — The Cleveland Clinic
• Study coordinator: Amy Attaway, MD

Conditions: COPD, Emphysema, Sarcopenia, emphysema, sarcopenia