Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
Primary outcome measures
- Exercise capacity [Time frame: 6 minutes]
- Arterial Stiffness [Time frame: 20 minutes]
- Muscle Oxygenation [Time frame: 10 minutes]
- Physical Activity [Time frame: 5 minutes]
Secondary outcome measures (12)
- Body Composition [Time frame: 5 minutes]
- Respiratory Muscle Strength [Time frame: 10 minutes]
- Peripheral Muscle Strength [Time frame: 5 minutes]
- Sleep Quality [Time frame: 5 minutes]
- COPD Assessment Test [Time frame: 5 minutes]
- Quality of Life [Time frame: 10 minutes]
- Symptoms [Time frame: 8 minutes]
- Pulmonary Function Test (forced vital capacity (FVC)) [Time frame: 10 minutes]
- Pulmonary Function Test (forced expiratory volume in the first second (FEV1)) [Time frame: 10 minutes]
- Pulmonary Function Test (FEV1/FVC) [Time frame: 10 minutes]
- Pulmonary Function Test (peak flow rate (PEF)) [Time frame: 10 minutes]
- Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%)) [Time frame: 10 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University — Ankara
Identifiers
NCT: NCT06682832 · HU-FTR-KUMLUE-01