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

NCT ID: NCT06682832

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-11-30

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Preserved Ratio Impaired Spirometry (PRISM)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COPD group

Consisted of 18 individuals over 40 years of age with chronic obstructive pulmonary disease.

No interventions assigned to this group

PRISm group

Consisted of 18 individuals over 40 years of age with preserved ratio impaired spirometry.

No interventions assigned to this group

Healthy group

Consisted of 18 healthy individuals over 40 years of age.

No interventions assigned to this group

Eligibility Criteria

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

• Being >40 years old,
• Being diagnosed with COPD,
• To be clinically stable,
• Volunteering to participate in the study.

• 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

• Being diagnosed with COPD,
• Severe orthopaedic, neurological and cardiac diseases
• Not volunteering to participate in the study

• Severe orthopaedic, neurological and cardiac diseases,
• Being in COPD exacerbation period,
• Not volunteering to participate in the study.

• Having a known chronic disease,
• Not volunteering to participate in the study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ece Kumlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ece Kumlu, M.Sc

Role: CONTACT

eekumlu@gmail.com

+90-312-305 2525 ext 178

Facility Contacts

Ece Kumlu

Role: primary

eekumlu@gmail.com

05535637892

Other Identifiers

HU-FTR-KUMLUE-01

Identifier Type: -

Identifier Source: org_study_id