Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. As research continues to evolve, PRISm needs to be recognized as a critical component of pulmonary assessments and at-risk individuals need to be provided with appropriate treatment and follow-up to prevent progression to COPD. There are no studies in the literature comparing PRISm, respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in COPD and healthy individuals. The aim of this study was to compare respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy subjects.
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.
Study Type
OBSERVATIONAL
Enrollment
54
Hacettepe University
Ankara, Turkey (Türkiye)
RECRUITINGExercise capacity
Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.
Time frame: 6 minutes
Arterial Stiffness
Arterial stiffness is evaluated with a Tel-O-Graph CT device with oscillometric cuff (I.E.M., Stolberg, Germany). Central systolic blood pressure, pulse wave velocity (PWV) and augmentation index (Alx) are measured with brachial pulse waves. After a five-minute rest, three measurements are performed in a quiet environment.
Time frame: 20 minutes
Muscle Oxygenation
Muscle oxygenation is assessed using a measurement and monitoring device (Moxy Fortiori Design LLC, Minnesota, USA). The device is placed on the vastus lateralis muscle. Resting measurements are taken for at least 3 minutes until the muscle oxygen saturation (SmO2) signal stabilizes. SmO2 at rest, SmO2 during 6DYT and during the first minute of recovery, and mean SmO2 are recorded.
Time frame: 10 minutes
Physical Activity
Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.
Time frame: 5 minutes
Body Composition
Body composition is evaluated by Bioelectrical Impedance Analysis method. For body composition measurement, it is completed in an upright posture, without moving, leaving a space between the arms and torso, ensuring full contact of the hands and feet with the electrodes. Muscle mass, fat mass, body fat percentage (BMR) and lean body weight (LBW) values of the participants are recorded.
Time frame: 5 minutes
Respiratory Muscle Strength
Respiratory Muscle Strength is measured using a mouth pressure meter (MicroRPM, Micro Medical, Rochester, UK) and personalized antibacterial and antiviral disposable filters; maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) values are determined.
Time frame: 10 minutes
Peripheral Muscle Strength
Peripheral muscle strength is measured by knee extensor muscle strength measurement. Measurements are performed with a portable digital muscle strength measuring device (01165 Manual Muscle Tester, Lafayette Instrument Co. Lafayette, USA).
Time frame: 5 minutes
Sleep Quality
Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI). The scale assesses sleep quality and sleep disturbance over the past month. The scale includes 24 questions. The total PDQI score ranges from 0-21 points. A total score greater than 5 points indicates "poor sleep quality".
Time frame: 5 minutes
COPD Assessment Test
The COPD Assessment Test, COPD Assessment Test Questionnaire (CAT), is an eight-item self-reported scale scored on a 0-5 point scale to assess symptoms associated with COPD. As a clinical impact, a total score of less than 10 points is interpreted as few symptoms, while a score of more than 10 points is interpreted as more symptoms.
Time frame: 5 minutes
Quality of Life
Quality of Life will be assessed with the St George Respiratory Questionnaire (SGRQ). SGRQ is a 76-item health-related quality of life assessment questionnaire.
Time frame: 10 minutes
Symptoms
Symptoms, dyspnea and fatigue level are assessed. Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. Fatigue levels of individuals will be assessed using the Fatigue Severity Scale (FSS).
Time frame: 8 minutes
Pulmonary Function Test (forced vital capacity (FVC))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced vital capacity (FVC). FVC is the volume of air exhaled with rapid and forceful exhalation following deep inspiration.
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory volume in the first second (FEV1). Forced vital capacity is the volume of air removed in the first second from the start of the maneuver.
Time frame: 10 minutes
Pulmonary Function Test (FEV1/FVC)
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses FEV1/FVC.
Time frame: 10 minutes
Pulmonary Function Test (peak flow rate (PEF))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses peak flow rate (PEF). PEF is measured by maximal inspiration followed by maximal exhalation maneuver.
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory flow from 25-75% (FEF25-75%). FEF25-75% mean flow rate at 50% of the forced vital capacity maneuver.
Time frame: 10 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.