- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07573826
Effect of Pursed-Lip Breathing With Different I:E Ratios on Respiratory Outcomes in COPD Patients (PLB I:E Ratio)
Effectiveness of Different Inspiratory-Expiratory Ratios (1:3, 1:4, and 1:5) in Pursed-Lip Breathing on Respiratory Rate, Oxygen Saturation, and Dyspnea in Patients With Chronic Obstructive Pulmonary Disease: A Quasi-Experimental Study
The goal of this clinical trial is to evaluate whether different inspiratory-expiratory (I:E) ratios in the pursed-lip breathing (PLB) technique can improve respiratory outcomes in patients with stable Chronic Obstructive Pulmonary Disease (COPD) aged 40 years and older. The primary purpose is to determine whether a specific breathing intervention can improve respiratory function.
The main questions it aims to answer are:
Does PLB with different I:E ratios (1:3, 1:4, and 1:5) reduce respiratory rate in COPD patients? Does PLB with different I:E ratios improve oxygen saturation and reduce dyspnea severity?
Researchers will compare PLB with I:E ratios of 1:3, 1:4, and 1:5 and a control group receiving standard care to see if different ratios produce different effects on respiratory rate, oxygen saturation, and dyspnea levels.
Participants will:
Perform pursed-lip breathing using assigned I:E ratios (1:3, 1:4, or 1:5) for 10 minutes Be assigned to either an intervention group or a control group (standard care) Have their respiratory rate measured before and after the intervention Have their oxygen saturation measured using a pulse oximeter Report their dyspnea level using the Modified Borg Scale before and after the intervention
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Sonstiges: Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration)
- Sonstiges: Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration)
- Sonstiges: Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration)
Detaillierte Beschreibung
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by persistent airflow limitation, dyspnea, and impaired gas exchange. It remains a leading cause of morbidity and mortality worldwide, with a disproportionately high burden in low- and middle-income countries. Dyspnea is one of the most debilitating symptoms experienced by COPD patients and is closely associated with reduced functional capacity and quality of life. Non-pharmacological interventions, particularly breathing exercises, play an important role in symptom management.
Pursed-lip breathing (PLB) is a simple, low-cost, and widely recommended breathing technique in COPD management. It works by prolonging the expiratory phase, increasing positive airway pressure, preventing airway collapse, and improving ventilation efficiency. Despite its widespread use, there is currently no standardized inspiratory-expiratory (I:E) ratio for PLB. Variations in clinical practice may result in inconsistent outcomes, and evidence comparing different I:E ratios remains limited.
This study aims to evaluate the effectiveness of three commonly recommended I:E ratios (1:3, 1:4, and 1:5) in PLB on respiratory outcomes in patients with stable COPD. The outcomes of interest include respiratory rate, peripheral oxygen saturation (SpO₂), and dyspnea severity as measured by the Modified Borg Scale. By comparing these ratios, the study seeks to identify the most effective breathing pattern for optimizing respiratory function.
This study employs a quasi-experimental design with a pretest-posttest control group approach. A total of 122 participants diagnosed with stable COPD will be recruited from Respira Hospital Yogyakarta, Indonesia. Participants will be randomly assigned into four groups: three intervention groups receiving PLB with different I:E ratios (1:3, 1:4, and 1:5), and one control group receiving standard care without structured PLB intervention.
The intervention will be conducted in a controlled clinical setting. Participants in the intervention groups will be instructed to perform PLB in a seated high-Fowler position for 10 minutes under supervision. Each group will follow a specific breathing pattern: inhalation through the nose followed by prolonged exhalation through pursed lips according to the assigned I:E ratio. The control group will receive standard care without guided PLB.
Outcome measurements will be taken at baseline (pre-intervention) and immediately after the intervention. Respiratory rate will be measured by direct observation for one minute, oxygen saturation will be assessed using a calibrated pulse oximeter, and dyspnea will be evaluated using the Modified Borg Scale (0-10). Data will be analyzed using appropriate statistical tests to compare within-group and between-group differences.
This study is expected to contribute to the development of evidence-based guidelines for PLB implementation in COPD management, particularly in determining the optimal I:E ratio. The findings may help standardize clinical practice, improve respiratory outcomes, and enhance the quality of life of COPD patients. Additionally, the results may provide a foundation for future research on breathing techniques and non-pharmacological interventions in respiratory care.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Scholastica Fina Aryu Puspasari, Master
- Telefonnummer: +62821-3433-1244
- E-Mail: scholastica_fina@stikespantirapih.ac.id
Studieren Sie die Kontaktsicherung
- Name: Bernadeta Eka Noviati, Magister
- Telefonnummer: +62 896-2816-5916
- E-Mail: eka_noviati@stikespantirapih.ac.id
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Diagnosed with stable COPD
- Age ≥ 40 years
- Able to follow breathing instructions
- Willing to participate and provide informed consent
Exclusion Criteria:
- Cognitive impairment or decreased consciousness
- Severe cardiovascular disease (heart failure, coronary artery disease, pulmonary hypertension)
- Asthma-COPD overlap (ACO)
- Acute respiratory infection (e.g., pneumonia)
- Neuromuscular disorders affecting respiratory muscles
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm Group 1, PLB I:E 1:3
Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration)
|
Participants will be allocated into four study arms: three intervention groups and one control group. Intervention Groups (PLB with Different I:E Ratios): Participants in the intervention arms will perform Pursed-Lip Breathing (PLB) with specific inspiratory-to-expiratory (I:E) ratios as follows: Group 1: I:E ratio 1:3 (2 seconds inspiration, 6 seconds expiration) The procedure will be conducted in a seated position (high Fowler's position). Participants will be instructed to inhale slowly through the nose and exhale through pursed lips according to the assigned ratio. A metronome will be used to standardize breathing timing. Each session will last approximately 10 minutes and will be supervised by the researcher to ensure correct technique and safety. stru |
|
Experimental: Arm Group 2, PLB I:E 1:4
Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration)
|
Participants will be allocated into four study arms: three intervention groups and one control group. Intervention Groups (PLB with Different I:E Ratios): Participants in the intervention arms will perform Pursed-Lip Breathing (PLB) with specific inspiratory-to-expiratory (I:E) ratios as follows: Group 2: I:E ratio 1:4 (2 seconds inspiration, 8 seconds expiration) The procedure will be conducted in a seated position (high Fowler's position). Participants will be instructed to inhale slowly through the nose and exhale through pursed lips according to the assigned ratio. A metronome will be used to standardize breathing timing. Each session will last approximately 10 minutes and will be supervised by the researcher to ensure correct technique and safety. |
|
Experimental: Arm Group 3, PLB I:E 1:5
Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration)
|
Participants will be allocated into four study arms: three intervention groups and one control group. Intervention Groups (PLB with Different I:E Ratios): Participants in the intervention arms will perform Pursed-Lip Breathing (PLB) with specific inspiratory-to-expiratory (I:E) ratios as follows: Group 3: I:E ratio 1:5 (2 seconds inspiration, 10 seconds expiration) The procedure will be conducted in a seated position (high Fowler's position). Participants will be instructed to inhale slowly through the nose and exhale through pursed lips according to the assigned ratio. A metronome will be used to standardize breathing timing. Each session will last approximately 10 minutes and will be supervised by the researcher to ensure correct technique and safety. |
|
Kein Eingriff: Arm Group 4, Standard Therapy
Participants receive standard care without structured PLB intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Primary Outcome 1: Respiratory Rate
Zeitfenster: Baseline and immediately after 10-minute intervention
|
Respiratory rate measured as the number of breaths per minute at rest using direct observation for 60 seconds
|
Baseline and immediately after 10-minute intervention
|
|
Primary Outcome 2: Oxygen Saturation (SpO₂)
Zeitfenster: Baseline and immediately after 10-minute intervention
|
Peripheral oxygen saturation measured using a calibrated pulse oximeter at rest.
|
Baseline and immediately after 10-minute intervention
|
|
Primary Outcome 3 Dyspnea Level
Zeitfenster: Baseline and immediately after 10-minute intervention
|
Dyspnea assessed using the Modified Borg Scale (0-10), where higher scores indicate more severe breathlessness.
|
Baseline and immediately after 10-minute intervention
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Scholastica FA Puspasari, Master, STIKes Panti Rapih Yogyakarta
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Hammoda Abu-Odah, Liu, N. X.-L., Wang, T., Zhao, I. Y., Yorke, J., Tan, J.-Y. B., & Molassiotis, A. (2025). Modified Borg Scale (mBorg), the numerical rating scale (NRS), and the Dyspnea-12 scale (D-12): Cross-scale comparison assessing the development of dyspnea in early-stage lung cancer patients. Supportive Care in Cancer, 33(5). https://doi.org/10.1007/s00520-025-09474-x
- Gusmarta, G., & Oktarina, Y. (2025). Case Report : Implementation of Pursed-Lips Breathing Technique on Respiratory Rate and Oxygen Saturation in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Pulmonary Ward of Raden Mattaher Hospital Jambi. Jurnal Keperawatan Universitas Jambi, 9(3), 8-12. https://doi.org/10.22437/jkuj.v9i3.47490
- Cavalheri, V., Burtin, C., Formico, V. R., Nonoyama, M., Jenkins, S., Spruit, M. A., & Hill, K. (2020). Exercise training for people with chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews, (4), CD010039. https://doi.org/10.1002/14651858.CD010039.pub2
- Burge, A. T., Gadowski, A. M., Jones, A., Romero, L., Smallwood, N. E., Ekström, M., Reinke, L. F., Saggu, R., Wijsenbeek, M., & Holland, A. E. (2024). Breathing techniques to reduce symptoms in people with serious respiratory illness: A systematic review. European Respiratory Review, 33(174), 240012. https://doi.org/10.1183/16000617.0012-2024
- Bhatt, S. P., Nakhmani, A., Fortis, S., Strand, M. J., Silverman, E. K., Sciurba, F. C., et al. (2023). FEV1/FVC severity stages for chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine, 208(6), 676-684. https://pubmed.ncbi.nlm.nih.gov/37339502/
- Anon. (2025, March 4). What is the recommended inspiratory to expiratory (I:E) ratio for ventilator settings in chronic obstructive pulmonary disease (COPD) exacerbation? Droracle.ai. https://www.droracle.ai/articles/22727/what-is-the-recommended-inspiratory-to-expiratory-ie-ratio
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Chronische Erkrankung
- Krankheitsattribute
- Erkrankungen der Atemwege
- Lungenkrankheit
- Lungenerkrankungen, obstruktive
- Pathologische Zustände, Anzeichen und Symptome
- Lungenerkrankung, chronisch obstruktiv
- Kreisende und respiratorische physiologische Phänomene
- Atemmechanik
- Atmung
- Respiratorische physiologische Phänomene
- Inhalation
- Exhalation
Andere Studien-ID-Nummern
- 0511028601
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Studiendaten/Dokumente
-
Studienprotokoll
Informationskennung: scholastica finaInformationskommentare: PLB Ratio
-
Einzelner Teilnehmerdatensatz
Informationskennung: scholastica_fina@stikespantiraInformationskommentare: In excel formula
-
Statistischer Analyseplan
Informationskennung: scholastica_fina@stikespantiraInformationskommentare: Interventional (Clinical Trial)
-
Einwilligungserklärung
Informationskennung: scholastica_fina@stikespantiraInformationskommentare: PIS and IC
-
Charter des Datenüberwachungsausschusses
Informationskennung: scholastica_fina@stikespantiraInformationskommentare: DMC
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .