What this study is
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.
What's being tested
- Multidisciplinary clinic evaluation
Intervention · OTHER
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.
- COPD standard of care
Intervention · OTHER
Standard COPD care treatment in an ambulatory post-hospital follow up clinic
Study details
- Sponsor
- The Cleveland Clinic
- Conditions
- COPD · Emphysema · Sarcopenia
- Enrolling
- 80 people
- Starts
- 2025-10-10
- Est. completion
- 2027-12-01
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic Foundation
Cleveland, Ohio, United States
- Amy Attaway, MD · Contact
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 25-857
Principal investigator
Amy Attaway, MD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.