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Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry

NCT06682832 · Hacettepe University
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Official title
Comparison of Exercise Capacity, Muscle Strength and Oxygenation, Arterial Stiffness, Physical Activity and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease and Impaired Spirometry With Preserved Ratio
About this study
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable multisystemic lung disease characterised by chronic respiratory symptoms (dyspnoea, cough, expectoration and/or exacerbations) due to abnormalities in the airways causing permanent and often progressive airflow limitation. In a part of the individuals with affected lung function, FEV1/FVC is preserved after bronchodilation (≥ 70%), whereas FEV1 is lower than expected (\< 80%). This condition, which describes a preserved ratio impaired spirometry (PRISm), is highly prevalent in current and former smokers. PRISm is defined as a spirometry pattern that is not always a stable phenotype, but should be considered ''patient'' because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. There are studies showing that pulmonary functions, exercise capacity and quality of life are impaired in individuals with PRISm, whose pathophysiology is unclear and clinical effects are not known. In addition to the insufficient number of studies investigating exercise capacity, quality of life and pulmonary function on behalf of PRISm in the literature, no previous studies comparing respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy individuals have been found. In this study, aimed to investigate whether the parameters (symptoms, respiratory and peripheral muscle strength, physical activity level, exercise capacity, muscle oxygenation, arterial stiffness), which have been proven to be affected in the COPD group due to their clinical similarity with COPD, are affected in the PRISm group. A total of 54 individuals, 18 in each group, will be included in the study. Pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life will be compared in PRISm, COPD and healthy individuals. Our study will be able to reveal the clinical status of PRISM patients in terms of pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life compared to COPD group and healthy group and will be a guide in planning pulmonary rehabilitation programmes.
Eligibility criteria
Inclusion Criteria: PRISm group inclusion criteria; * Being \>40 years old, * Being diagnosed with PRISm, * Volunteering to participate in the study, * Not having any orthopaedic or neurological problems that may prevent participation in the measurements, * Co-operation with measurements Inclusion criteria for the COPD group; * Being \>40 years old, * Being diagnosed with COPD, * To be clinically stable, * Volunteering to participate in the study. Inclusion criteria for healthy individuals; * Being \>40 years old, * Volunteering to participate in the study, * No known chronic health problems, * To be able to co-operate with the measurements. Exclusion Criteria: PRISm group exclusion criteria; * Being diagnosed with COPD, * Severe orthopaedic, neurological and cardiac diseases * Not volunteering to participate in the study Exclusion criteria for COPD group; * Severe orthopaedic, neurological and cardiac diseases, * Being in COPD exacerbation period, * Not volunteering to participate in the study. Healthy individuals exclusion criteria; * Having a known chronic disease, * Not volunteering to participate in the study
Study design
Enrollment target: 54 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-09-18
Estimated completion: 2026-09
Last updated: 2026-03-31
Primary outcomes
  • Exercise capacity (6 minutes)
  • Arterial Stiffness (20 minutes)
  • Muscle Oxygenation (10 minutes)
Sponsor
Hacettepe University · other
Contacts & investigators
ContactEce Kumlu, M.Sc · contact · eekumlu@gmail.com · +90-312-305 2525 ext 178
All locations (1)
Hacettepe UniversityRecruiting
Ankara, Turkey (Türkiye)
Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry · TrialPath