Comparison of Patients With COPD and PRISM

NCT07249567 | Recruiting

• 1 other identifier: Karabuk-2383
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. PRISm can predispose to the development of COPD and exacerbations, and can reduce exercise capacity by reducing respiratory function and oxygen consumption. There are no studies in the literature comparing respiratory muscle strength, peripheral muscle strength, and oxygenation in PRISm, COPD, and healthy individuals. Therefore, this study aimed to evaluate these parameters and compare them with healthy individuals.

Conditions

COPD

Outcome Measures

Primary Outcomes (8)

• Upper extremity exercise capacity

  Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).

  Baseline

• Lower extremity exercise capacity

  Lower extremity exercise capacity will be evaluated with six- minute walking test.

  Baseline

• Peripheral muscle strength

  Peripheral muscle strength will be evaluated with a dynamometer.

  Baseline

• Muscle oxygenation

  Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).

  Baseline

• Respiratory Muscle Strength

  Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.

  Baseline

• Respiratory Muscle Endurance

  Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.

  Baseline

• Dyspnea

  Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.

  Baseline

• Clinical symptoms

  The COPD Assessment Test will be evaluated. This scale scored on a 0-5 point scale to assess symptoms associated with COPD. As the score increases, the symptom increases.

  Baseline

Secondary Outcomes (5)

• Pulmonary function (Forced vital capacity (FVC)

  Baseline

• Pulmonary function (Forced expiratory volume in the first second (FEV1)

  Baseline

• Pulmonary function (FEV1 / FVC)

  Baseline

• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

  Baseline

• Pulmonary function (Peak flow rate (PEF))

  Baseline

Study Arms (3)

Patients with COPD

Patients with chronic obstructive pulmonary disease will be included.

Patients with PRISm

Patients with preserved ratio impaired spirometry will be included.

Control

Healthy controls will be included.

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

Patients with COPD and PRSIm will be included and compared with healthy controls

You may qualify if:

• For the COPD group:
• Being \>40 years old,
• Being diagnosed with COPD,
• Being clinically stable,
• Volunteering to participate in the study.
• For the PRISm group:
• Being \>40 years old,
• Being diagnosed with PRISm,
• Volunteering to participate in the study.
• For the healthy control group:
• Being \>40 years old,
• Volunteering to participate in the study.

You may not qualify if:

• For the COPD group:
• Having severe orthopedic, neurological, or cardiac diseases,
• Being in a COPD exacerbation,
• Having a comorbid lung disease,
• Being on clinically unstable medication,
• Voluntarily not participating in the study.
• For the PRISm group:
• Being diagnosed with COPD,
• Having severe orthopedic, neurological, or cardiac diseases,
• Having a comorbid lung disease,
• Voluntarily not participating in the study.
• For the healthy control group:
• Having a known chronic disease,
• Voluntarily not participating in the study.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Musa Güneş, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Rabia Hande Avcı, MD

  Karabuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Musa Güneş, PhD

CONTACT

03704789081; musagunes52@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)