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Completed

NCT Number: NCT07509528

Sarcopenia Predictors 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.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Respiratory Muscle Strength Assessment

    Time frame: Day 1

    Respiratory muscle strength will be evaluated by mouth pressure measurement non-invasive method by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).

  2. Rectus femoris muscle thickness

    Time frame: Day 1

    The thickness and cross-sectional area of the rectus femoris portion of the quadriceps muscle were determined by ultrasound measurement.

  3. Activities of daily living (ADL)

    Time frame: Day 1

    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.

  4. Physical performance and lower extremity strength

    Time frame: Day 1

    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)]

  5. Balance and fall Risk

    Time frame: Day 1

    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.

  6. Physical performance and lower extremity function

    Time frame: Day 1

    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

  7. Dyspnea during daily life

    Time frame: Day 1

    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

  8. Health Status

    Time frame: Day 1

    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

  9. Depression

    Time frame: Day 1

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Bursa City Hospital

Registry information

Official study title

Examination of Factors Affecting Sarcopenia in Patients With COPD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2026
Registry last updated
Apr 9, 2026

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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