COPD (Chronic Obstructive Pulmonary Disease)NCT07509528
Sarcopenia Predictors in Patients With COPD
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Sarcopenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD) is a significant, preventable, and treatable public health problem and a growing cause of chronic morbidity and mortality worldwide. Frailty is a biological syndrome resulting from a progressive decrease in the reserve capacity of multiple physiological systems. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia, Frailty
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This study will be conducted with COPD patients referred to the Physical Therapy and Rehabilitation Department of Bursa City Hospital for cardiopulmonary rehabilitation. For sample size analysis, the study by Tsekoura et al., which examined the prevalence of sarcopenia and factors affecting sarcopenia among COPD patients, was used. Sample size analysis was performed using the SCALEX SP program (Heinrich Heine University, Düsseldorf, Germany). Based on the frailty prevalence (24.6%) in the study by Tsekoura et al., and considering the 20% patient mortality rate, at least 41 COPD patients need to be included in the study to reach the required significance level of 0.05.
Who may be able to join
- Individuals who were clinically stable for the past month and not using antibiotics,
- 40 years of age and older, cooperative, able to ambulate without support or assistive devices,
- diagnosed with and followed up at the Chest Diseases Outpatient Clinic of Bursa City Hospital,
- evaluated for sarcopenia by an internal medicine and geriatrics specialist,
- and volunteered to participate in the study were included.
Who cannot join
- Individuals with any additional neuromuscular, musculoskeletal, cardiac, rheumatological, neurological, psychiatric or orthopedic disease,
- other chronic diseases that may affect balance and walking,
- cognitive impairment (Mini Mental Test score <24) (13) were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Factors Affecting Sarcopenia in Patients With COPD
Chronic obstructive pulmonary disease (COPD) is a significant, preventable, and treatable public health problem and a growing cause of chronic morbidity and mortality worldwide. Frailty is a biological syndrome resulting from a progressive decrease in the reserve capacity of multiple physiological systems. COPD and frailty are closely associated with common risk factors such as aging, tobacco use, impaired neuroendocrine function, immune system dysfunction, and chronic inflammation.
Cardiopulmonary exercise testing (CPET) is a valuable tool for assessing exercise capacity, evaluating the severity of limitations, and identifying their causes. CPET provides an objective measurement of exercise capacity with direct applications in risk stratification. It also guides rehabilitation practices, including the planning and prescription of exercise training.
Read more
COPD is associated with a systemic inflammatory process that can lead to progressive loss of muscle mass and function and sarcopenia. The prevalence of COPD in sarcopenic patients varies between 4.4% and 86.55% due to the variability of various diagnostic tools, different reference values, and threshold values presented in the literature Further research is needed in the literature regarding the role of sarcopenia and factors that may affect sarcopenia, such as cardiorespiratory exercise capacity, in a specific lung disease like COPD.
The primary aim of this study was to examine the differences in respiratory function, respiratory muscle strength, cardiopulmonary exercise capacity, rectus femoris muscle thickness, activities of daily living, balance, and frailty parameters among patients with possible sarcopenic, sarcopenic, and severe sarcopenic COPD.
The secondary aim of this study was to identify the factors affecting sarcopenia in COPD patients.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a significant, preventable, and treatable public health problem and a growing cause of chronic morbidity and mortality worldwide. Currently, COPD is among the top three causes of death globally. Very often, the combination of impaired lung function and comorbidities leads to frailty and physical weakness. Estimates of frailty among individuals with COPD range widely; for example, 10% for a Dutch study, 11% for a Japanese study, approximately 25% for two UK studies, and 18% and 58% for US populations. Frailty is a biological syndrome resulting from a progressive decrease in the reserve capacity of multiple physiological systems . COPD and frailty are closely associated with common risk factors such as aging, tobacco use, impaired neuroendocrine function, immune system dysfunction, and chronic inflammation.
Dyspnea and exercise intolerance are common symptoms of COPD. COPD patients exhibit decreased exercise tolerance due to critical inspiratory restriction of possible tidal volume (Vt) expansion during exercise, decreased oxygen availability, and gas exchange abnormalities. Cardiopulmonary exercise testing (CPET) is a valuable tool for assessing exercise capacity, evaluating the severity of limitations, and identifying their causes. COPD is a heterogeneous condition in which physical function can be impaired through multiple mechanisms. CPET provides an objective measurement of exercise capacity with direct applications in risk stratification. It also guides rehabilitation practices, including the planning and prescription of exercise training.
Sarcopenia is a disorder that defines age-related loss of muscle mass and decreased muscle strength, and it develops due to several factors, including inflammation and chronic disease. COPD is associated with a systemic inflammatory process that can lead to progressive loss of muscle mass and function and sarcopenia. Layton et al. showed that frail lung transplant candidates have reduced exercise capacity disproportionate to the severity of their lung disease. They assessed exercise capacity with CPET. The prevalence of COPD in sarcopenic patients varies between 4.4% and 86.55% due to the variability of various diagnostic tools, different reference values, and threshold values presented in the literature. Although knowing the prevalence and diagnostic methods of COPD and sarcopenia is crucial for researching effective prevention and intervention strategies, further research is still needed in this area.
In one study, the prevalence of sarcopenia in COPD patients was found to be 24.6%. Sarcopenia was associated with decreased muscle strength and mass, walking speed, and decreased body mass index in COPD patients. Further research is needed in the literature regarding the role of sarcopenia and factors that may affect sarcopenia, such as cardiorespiratory exercise capacity, in a specific lung disease like COPD.
The primary aim of this study was to examine the differences in respiratory function, respiratory muscle strength, cardiopulmonary exercise capacity, rectus femoris muscle thickness, activities of daily living, balance, and frailty parameters among patients with possible sarcopenic, sarcopenic, and severe sarcopenic COPD.
The secondary aim of this study was to identify the factors affecting sarcopenia in COPD patients.
- Keywords
- Chronic obstructive pulmonary disease, Sarcopenia, Frailty, Balance, Peak oxygen uptake
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sarcopenia, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Frailty
In patients with COPD, the frail phenotype was determined according to the five-parameter frailty criteria established by Fried et al.
Measured: Day 1
Sarcopenia Assessment
The assessment was conducted according to the operational definition revised by the European Sarcopenia Study Group (EWGSOP) in 2019 under the name EWGSOP-2 criteria.
Measured: Day 1
Cardiopulmonary exercise capacity
Cardiopulmonary exercise capacity was assessed using a cardiopulmonary exercise test (CPET). The CPET was performed using a Quark CPET device (Cosmed, Rome, Italy) with breath-by-breath measurement. The procedure was carried out according to the modified Bruce protocol.
Measured: Day 2
Secondary outcomes (9)
Respiratory Muscle Strength Assessment
Respiratory muscle strength will be evaluated by mouth pressure measurement non-invasive method by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: Day 1
Rectus femoris muscle thickness
The thickness and cross-sectional area of the rectus femoris portion of the quadriceps muscle were determined by ultrasound measurement.
Measured: Day 1
Activities of daily living (ADL)
Activities of daily living (ADL) were assessed using the London Chest Activities of Daily Living Scale. The maximum total score is 75, and higher scores indicate a deficiency in ADL.
Measured: Day 1
Physical performance and lower extremity strength
Total completion duration was recorded during 5 times sit to stand during the 5-times sit-to-stand (5STS) test. The poor performance during 5STS was considered worse than normative values based on age [11.4 sec (60 to 69 years), 12.6 sec. (70 to 79 years), and 14.8 sec. (80 to 89 years)]
Measured: Day 1
Balance and fall Risk
The Timed-Up and Go test (TUG) measures the time required for a patient to stand up from a chair, walk 3 m, turn, return, and sit down, recorded in seconds using a stopwatch. ≥12 seconds is a criteria for fall risk in older adults.
Measured: Day 1
Physical performance and lower extremity function
Short Physical Performance Battery (SPPB) is a composite measure that evaluates physical performance, lower extremity function and fall risk through three components: gait speed, balance, and chair stand tests. The total score ≤6 indicates poor physical performance and increased fall risk
Measured: Day 1
Dyspnea during daily life
The Modified Medical Research Council (mMRC) dyspnea scale was used to determine the level of dyspnea in daily life. The mMRC scale is a category scale that evaluates shortness of breath on a scale of 0-4 points. A higher score indicates higher dyspnea perception
Measured: Day 1
Health Status
Health status was assessed using the COPD Assessment Test (CAT). The CAT consists of eight items, each one scored from 0 to 5 (0=no defect). The total score range between 0-40 points. The CAT scores of 0-10, 11-20, 21-30, and 31-40 indicate mild, moderate, severe, and very severe clinical status, respectively
Measured: Day 1
Depression
The Turkish valid and reliable version of Beck Depression Inventory (BDI) is a 21-item, four-point Likert-type scale used to assess the severity of depressive symptoms. Each item is scored 0-3, yielding a total score between 0 and 63. Total BDI scores are interpreted as 0-9: no depression, 10-18: mild, 19-29: moderate, and 30-63: severe depression
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jun 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa City Hospital
- Responsible party
- Principal investigator, Ebru Calik, Hacettepe University
- Investigators
- Sezen Kayalı, MsC, Study director, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509528
- Sponsor's protocol ID
- 2024-9/14
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Factors Affecting Sarcopenia in Patients With COPD
- ClinicalTrials.gov ID
- NCT07509528
- Acronym / sponsor ID
- 2024-9/14
- Keywords
- Chronic obstructive pulmonary disease, Sarcopenia, Frailty, Balance, Peak oxygen uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Bursa City Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 3 Apr 2026 (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.
Chronic obstructive pulmonary disease (COPD) is a significant, preventable, and treatable public health problem and a growing cause of chronic morbidity and mortality worldwide. Frailty is a biological syndrome resulting from a progressive decrease in the reserve capacity of multiple physiological systems. COPD and frailty are closely associated with common risk factors such as aging, tobacco use, impaired neuroendocrine function, immune system dysfunction, and chronic inflammation.
Cardiopulmonary exercise testing (CPET) is a valuable tool for assessing exercise capacity, evaluating the severity of limitations, and identifying their causes. CPET provides an objective measurement of exercise capacity with direct applications in risk stratification. It also guides rehabilitation practices, including the planning and prescription of exercise training.
COPD is associated with a systemic inflammatory process that can lead to progressive loss of muscle mass and function and sarcopenia. The prevalence of COPD in sarcopenic patients varies between 4.4% and 86.55% due to the variability of various diagnostic tools, different reference values, and threshold values presented in the literature Further research is needed in the literature regarding the role of sarcopenia and factors that may affect sarcopenia, such as cardiorespiratory exercise capacity, in a specific lung disease like COPD.
The primary aim of this study was to examine the differences in respiratory function, respiratory muscle strength, cardiopulmonary exercise capacity, rectus femoris muscle thickness, activities of daily living, balance, and frailty parameters among patients with possible sarcopenic, sarcopenic, and severe sarcopenic COPD.
The secondary aim of this study was to identify the factors affecting sarcopenia in COPD patients.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a significant, preventable, and treatable public health problem and a growing cause of chronic morbidity and mortality worldwide. Currently, COPD is among the top three causes of death globally. Very often, the combination of impaired lung function and comorbidities leads to frailty and physical weakness. Estimates of frailty among individuals with COPD range widely; for example, 10% for a Dutch study, 11% for a Japanese study, approximately 25% for two UK studies, and 18% and 58% for US populations. Frailty is a biological syndrome resulting from a progressive decrease in the reserve capacity of multiple physiological systems . COPD and frailty are closely associated with common risk factors such as aging, tobacco use, impaired neuroendocrine function, immune system dysfunction, and chronic inflammation.
Dyspnea and exercise intolerance are common symptoms of COPD. COPD patients exhibit decreased exercise tolerance due to critical inspiratory restriction of possible tidal volume (Vt) expansion during exercise, decreased oxygen availability, and gas exchange abnormalities. Cardiopulmonary exercise testing (CPET) is a valuable tool for assessing exercise capacity, evaluating the severity of limitations, and identifying their causes. COPD is a heterogeneous condition in which physical function can be impaired through multiple mechanisms. CPET provides an objective measurement of exercise capacity with direct applications in risk stratification. It also guides rehabilitation practices, including the planning and prescription of exercise training.
Sarcopenia is a disorder that defines age-related loss of muscle mass and decreased muscle strength, and it develops due to several factors, including inflammation and chronic disease. COPD is associated with a systemic inflammatory process that can lead to progressive loss of muscle mass and function and sarcopenia. Layton et al. showed that frail lung transplant candidates have reduced exercise capacity disproportionate to the severity of their lung disease. They assessed exercise capacity with CPET. The prevalence of COPD in sarcopenic patients varies between 4.4% and 86.55% due to the variability of various diagnostic tools, different reference values, and threshold values presented in the literature. Although knowing the prevalence and diagnostic methods of COPD and sarcopenia is crucial for researching effective prevention and intervention strategies, further research is still needed in this area.
In one study, the prevalence of sarcopenia in COPD patients was found to be 24.6%. Sarcopenia was associated with decreased muscle strength and mass, walking speed, and decreased body mass index in COPD patients. Further research is needed in the literature regarding the role of sarcopenia and factors that may affect sarcopenia, such as cardiorespiratory exercise capacity, in a specific lung disease like COPD.
The primary aim of this study was to examine the differences in respiratory function, respiratory muscle strength, cardiopulmonary exercise capacity, rectus femoris muscle thickness, activities of daily living, balance, and frailty parameters among patients with possible sarcopenic, sarcopenic, and severe sarcopenic COPD.
The secondary aim of this study was to identify the factors affecting sarcopenia in COPD patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted with COPD patients referred to the Physical Therapy and Rehabilitation Department of Bursa City Hospital for cardiopulmonary rehabilitation. For sample size analysis, the study by Tsekoura et al., which examined the prevalence of sarcopenia and factors affecting sarcopenia among COPD patients, was used. Sample size analysis was performed using the SCALEX SP program (Heinrich Heine University, Düsseldorf, Germany). Based on the frailty prevalence (24.6%) in the study by Tsekoura et al., and considering the 20% patient mortality rate, at least 41 COPD patients need to be included in the study to reach the required significance level of 0.05.
Key inclusion criteria (5 listed)
- Individuals who were clinically stable for the past month and not using antibiotics,
- 40 years of age and older, cooperative, able to ambulate without support or assistive devices,
- diagnosed with and followed up at the Chest Diseases Outpatient Clinic of Bursa City Hospital,
- evaluated for sarcopenia by an internal medicine and geriatrics specialist,
- and volunteered to participate in the study were included.
Key exclusion criteria (3 listed)
- Individuals with any additional neuromuscular, musculoskeletal, cardiac, rheumatological, neurological, psychiatric or orthopedic disease,
- other chronic diseases that may affect balance and walking,
- cognitive impairment (Mini Mental Test score <24) (13) were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Frailty
Time frame: Day 1
In patients with COPD, the frail phenotype was determined according to the five-parameter frailty criteria established by Fried et al.
Sarcopenia Assessment
Time frame: Day 1
The assessment was conducted according to the operational definition revised by the European Sarcopenia Study Group (EWGSOP) in 2019 under the name EWGSOP-2 criteria.
Cardiopulmonary exercise capacity
Time frame: Day 2
Cardiopulmonary exercise capacity was assessed using a cardiopulmonary exercise test (CPET). The CPET was performed using a Quark CPET device (Cosmed, Rome, Italy) with breath-by-breath measurement. The procedure was carried out according to the modified Bruce protocol.
9 secondary outcomes
Respiratory Muscle Strength Assessment
Time frame: Day 1
Rectus femoris muscle thickness
Time frame: Day 1
Activities of daily living (ADL)
Time frame: Day 1
Physical performance and lower extremity strength
Time frame: Day 1
Balance and fall Risk
Time frame: Day 1
Physical performance and lower extremity function
Time frame: Day 1
Dyspnea during daily life
Time frame: Day 1
Health Status
Time frame: Day 1
Depression
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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. This study is not recruiting at the moment.
Sezen Kayalı, MsC study director
Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Sarcopenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 9 Apr 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Frailty (time frame: Day 1). 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 9 Apr 2026.