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NCT Number: NCT07059637

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Amy Attaway, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

COPD standard of care

Other

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

Primary outcomes

  1. Mortality

    Time frame: One year follow up

    Count

  2. Hospitalizations

    Time frame: One year follow up

    Count

  3. Number of COPD exacerbations

    Time frame: One year follow up

    Count

Secondary outcomes

  1. Handgrip strength

    Time frame: One year follow up

    kg

  2. Skeletal muscle mass by bioelectric impedance analysis

    Time frame: One year follow up

    kg/m^2

  3. 6-minute walk distance

    Time frame: One year follow up

    meters

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Attaway, MD

CONTACT

[email protected]

216-445-2807

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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