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

NCT07059637 | Recruiting

• 1 other identifier: 25-857
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; emphysema; sarcopenia

Outcome Measures

Primary Outcomes (3)

• Mortality

  Count

  One year follow up

• Hospitalizations

  Count

  One year follow up

• Number of COPD exacerbations

  Count

  One year follow up

Secondary Outcomes (3)

• Handgrip strength

  One year follow up

• Skeletal muscle mass by bioelectric impedance analysis

  One year follow up

• 6-minute walk distance

  One year follow up

Study Arms (2)

Sarcopenia clinic

ACTIVE COMPARATOR

Multidisciplinary sarcopenia clinic

Other: Multidisciplinary clinic evaluation

COPD standard of care clinic

ACTIVE COMPARATOR

Other: COPD standard of care

Interventions

Multidisciplinary clinic evaluation 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.

Sarcopenia clinic

COPD standard of care OTHER

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

COPD standard of care clinic

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Sarcopenia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Amy Attaway, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Attaway, MD

CONTACT

216-445-2807; attawaa@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 11, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)