Clinical trial NCT06682832: Comparison of Clinical Status of Individuals with COPD and Preserved Ratio Impaired Spirometry
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Preserved Ratio Impaired Spirometry (PRISM)
Keywords: COPD
PRISm
exercise capacity
muscle strength
arterial stiffness
physical activity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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

Primary outcomes:
measure: Exercise capacity
timeFrame: 6 minutes
measure: Arterial Stiffness
timeFrame: 20 minutes
measure: Muscle Oxygenation
timeFrame: 10 minutes
measure: Physical Activity
timeFrame: 5 minutes
Secondary outcomes:
measure: Body Composition
timeFrame: 5 minutes
measure: Respiratory Muscle Strength
timeFrame: 10 minutes
measure: Peripheral Muscle Strength
timeFrame: 5 minutes
measure: Sleep Quality
timeFrame: 5 minutes
measure: COPD Assessment Test
timeFrame: 5 minutes
measure: Quality of Life
timeFrame: 10 minutes
measure: Symptoms
timeFrame: 8 minutes
measure: Pulmonary Function Test (forced vital capacity (FVC))
timeFrame: 10 minutes
measure: Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
timeFrame: 10 minutes
measure: Pulmonary Function Test (FEV1/FVC)
timeFrame: 10 minutes
measure: Pulmonary Function Test (peak flow rate (PEF))
timeFrame: 10 minutes
measure: Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: