Sarcopenia Predictors in Patients With COPD

NCT07509528 | Completed

• 1 other identifier: 2024-9/14
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia; Frailty; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Chronic obstructive pulmonary disease; Sarcopenia; Frailty; Balance; Peak oxygen uptake

Outcome Measures

Primary Outcomes (3)

• Assessment of Frailty

  In patients with COPD, the frail phenotype was determined according to the five-parameter frailty criteria established by Fried et al.

  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.

  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.

  Day 2

Secondary Outcomes (9)

• Respiratory Muscle Strength Assessment

  Day 1

• Rectus femoris muscle thickness

  Day 1

• Activities of daily living (ADL)

  Day 1

• Physical performance and lower extremity strength

  Day 1

• Balance and fall Risk

  Day 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Individuals who were clinically stable for the past month and not using antibiotics,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Bursa City Hospital: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, 16250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Sezen Kayalı, MsC

  Bursa City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: June 1, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

TU (1)