Recruiting

Sarcopenia in COPD

Sponsor:

The Cleveland Clinic

Code:

NCT07059637

Conditions

COPD

Emphysema

Sarcopenia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Multidisciplinary clinic evaluation

COPD standard of care

Study Details

Brief 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.

Conditions

COPD

Emphysema

Sarcopenia

Study ID

NCT07059637

Start date

Oct 10, 2025

Status verified date

Oct, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sarcopenia clinic

Multidisciplinary sarcopenia clinic

active comparator: COPD standard of care clinic

Interventions

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.

COPD standard of care

Standard COPD care treatment in an ambulatory post-hospital follow up clinic

Primary outcome measure

  • Mortality [ Time Frame: One year follow up ]
  • Hospitalizations [ Time Frame: One year follow up ]
  • Number of COPD exacerbations [ Time Frame: One year follow up ]

Central Contacts and Locations

Central contacts

Amy Attaway, MD

216-445-2807attawaa@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • COPD
  • emphysema
  • sarcopenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-10-30.