COPDNCT07059637
Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
A study testing Multidisciplinary clinic evaluation in people with COPD and Emphysema, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Emphysema, Sarcopenia
- What is being tested?
- Multidisciplinary clinic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Amy Attaway, MD
About this study
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.
Read the 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
- Being tested
- Multidisciplinary clinic evaluation, COPD standard of care
- Keywords
- COPD, emphysema, sarcopenia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary clinic evaluationOther
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 careOther
Standard COPD care treatment in an ambulatory post-hospital follow up clinic
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia clinic | Active comparator | Multidisciplinary sarcopenia clinic Receives: Other: Multidisciplinary clinic evaluation |
| COPD standard of care clinic | Active comparator | Not described Receives: Other: COPD standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Count
Measured: One year follow up
Hospitalizations
Count
Measured: One year follow up
Number of COPD exacerbations
Count
Measured: One year follow up
Secondary outcomes (3)
Handgrip strength
kg
Measured: One year follow up
Skeletal muscle mass by bioelectric impedance analysis
kg/m^2
Measured: One year follow up
6-minute walk distance
meters
Measured: One year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Attaway, The Cleveland Clinic
- Investigators
- Amy Attaway, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059637
- Sponsor's protocol ID
- 25-857
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be sufficiently de-identified to protect participant confidentiality due to small sample size.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
- ClinicalTrials.gov ID
- NCT07059637
- Acronym / sponsor ID
- 25-857
- Conditions
- COPD, Emphysema, Sarcopenia
- Keywords
- COPD, emphysema, sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia clinic | Active comparator | Other: Multidisciplinary clinic evaluationMultidisciplinary sarcopenia clinic |
| COPD standard of care clinic | Active comparator | Other: COPD standard of care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary clinic evaluationThe 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. | Other | Sarcopenia clinic |
| COPD standard of careStandard COPD care treatment in an ambulatory post-hospital follow up clinic | Other | COPD standard of care clinic |
Primary outcome
Mortality
Time frame: One year follow up
Count
Hospitalizations
Time frame: One year follow up
Count
Number of COPD exacerbations
Time frame: One year follow up
Count
3 secondary outcomes
Handgrip strength
Time frame: One year follow up
Skeletal muscle mass by bioelectric impedance analysis
Time frame: One year follow up
6-minute walk distance
Time frame: One year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No. The data cannot be sufficiently de-identified to protect participant confidentiality due to small sample size.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Attaway, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary clinic evaluation in people with COPD and Emphysema, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Attaway, MD (216-445-2807, attawaa@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: One year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.