Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Being diagnosed with COPD,
Severe orthopaedic, neurological and cardiac diseases
Not volunteering to participate in the study
Severe orthopaedic, neurological and cardiac diseases,
Trial population
COPD and PRISm patients referred to the Cardiopulmonary Rehabilitation Unit for routine physiotherapy and rehabilitation will be included in the study. The group of healthy individuals will be formed by including the healthy siblings of the participants who are age and gender compatible with the COPD and PRISm groups, and the volunteers among the relatives and acquaintances of the researchers. 54 individuals will be included in the study.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
54 Participants
are grouped into 3 trial groupsGroup A: COPD group
Group B: PRISm group
Group C: Healthy group
Trial outcomes
Primary outcomes
1
Exercise 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 minutes2
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 minutes3
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 minutes4
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 minutesSecondary outcomes
1
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 minutes2
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 minutes3
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 minutes4
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 minutesSponsors and contacts
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Source ClinicalTrials.gov