Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Multidisciplinary clinic evaluation
Other interventionThe 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 interventionStandard COPD care treatment in an ambulatory post-hospital follow up clinic
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Sarcopenia clinicActive comparator 1 intervention
Group B: COPD standard of care clinicActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Count
Time frame
One year follow up2
Hospitalizations
Count
Time frame
One year follow up3
Number of COPD exacerbations
Count
Time frame
One year follow upSecondary outcomes
1
Handgrip strength
kg
Time frame
One year follow up2
Skeletal muscle mass by bioelectric impedance analysis
kg/m\^2
Time frame
One year follow up3
6-minute walk distance
meters
Time frame
One year follow upSponsors and contacts
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Source ClinicalTrials.gov