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

NCT ID: NCT07059637

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2027-12-01

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarcopenia clinic

Multidisciplinary sarcopenia clinic

Group Type: ACTIVE_COMPARATOR

Multidisciplinary clinic evaluation

Intervention Type: 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 clinic

Group Type: ACTIVE_COMPARATOR

COPD standard of care

Intervention Type: OTHER

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

Intervention Type: OTHER

COPD standard of care

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amy Attaway

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Attaway, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Attaway, MD

Role: CONTACT

attawaa@ccf.org

216-445-2807

Facility Contacts

Amy Attaway, MD

Role: primary

Other Identifiers

25-857

Identifier Type: -

Identifier Source: org_study_id