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

NCT06682832 | Recruiting

• 1 other identifier: HU-FTR-KUMLUE-01
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COPD; PRISm; exercise capacity; muscle strength; arterial stiffness; physical activity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  5 minutes

Secondary Outcomes (12)

• Body Composition

  5 minutes

• Respiratory Muscle Strength

  10 minutes

• Peripheral Muscle Strength

  5 minutes

• Sleep Quality

  5 minutes

• COPD Assessment Test

  5 minutes

Study Arms (3)

COPD group

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

PRISm group

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

Healthy group

Consisted of 18 healthy individuals over 40 years of age.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ece Kumlu, M.Sc

CONTACT

+90-312-305 2525 ext 178; eekumlu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)