NCT07059637

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COPD
• Emphysema
• Sarcopenia

Interventions

Type	Name	Description
OTHER	Multidisciplinary clinic evaluation	The goal is to use evidence-based strategies to diagnose and treat sarcopenia due to COPD. 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 hospitalizations, COPD exacerbations, or mortality. The approach is different than standard of care COPD treatment because it is informed by quantifying muscle mass and strength (through handgrip strength and bio-impedance) and have strong collaborations with nutrition and pulmonary rehabilitation.
OTHER	COPD standard of care	Standard COPD care treatment in an ambulatory post-hospital follow up clinic

Timeline

• Start date: 2025-10-10
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-07-11
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States