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NCT Number: NCT07249567

Comparison of Patients With COPD and PRISM

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location status: Recruiting

Location contact

Musa Güneş, MsC

CONTACT

[email protected]

03704189081

About this study

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable multisystem lung disease characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to airway abnormalities, causing persistent and often progressive airflow limitation. PRISm is defined as a spirometry pattern that is not always a stable phenotype but should be considered "sick" because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. Recently, PRISm has been identified as a subtype more prone to developing COPD or experiencing acute exacerbations. In addition to affecting the respiratory muscles, PRISm's effects on respiratory function lead to decreased body oxygen consumption and increased dyspnea. PRISm can also lead to decreased exercise capacity due to the respiratory problems and dyspnea it causes. Although there are not enough studies in the literature investigating exercise capacity and lung functions on behalf of PRISm, no previous study comparing respiratory muscle strength, peripheral muscle strength and oxygenation in PRISm, COPD and healthy individuals has been found.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Upper extremity exercise capacity

    Time frame: Baseline

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

  2. Lower extremity exercise capacity

    Time frame: Baseline

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

  3. Peripheral muscle strength

    Time frame: Baseline

    Peripheral muscle strength will be evaluated with a dynamometer.

  4. Muscle oxygenation

    Time frame: Baseline

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

  5. Respiratory Muscle Strength

    Time frame: Baseline

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

  6. Respiratory Muscle Endurance

    Time frame: Baseline

    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.

  7. Dyspnea

    Time frame: Baseline

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

  8. Clinical symptoms

    Time frame: Baseline

    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.

Secondary outcomes

  1. Pulmonary function (Forced vital capacity (FVC)

    Time frame: Baseline

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.

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

    Time frame: Baseline

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.

  3. Pulmonary function (FEV1 / FVC)

    Time frame: Baseline

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.

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

    Time frame: Baseline

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.

  5. Pulmonary function (Peak flow rate (PEF))

    Time frame: Baseline

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Musa Güneş, PhD

CONTACT

[email protected]

03704789081

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Comparison of Respiratory and Peripheral Muscle Strength, Exercise Capacity, and Muscle Oxygenation in Individuals With COPD and PRISM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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