- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Altro: Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration)
- Altro: Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration)
- Altro: Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration)
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Scholastica Fina Aryu Puspasari, Master
- Numero di telefono: +62821-3433-1244
- Email: scholastica_fina@stikespantirapih.ac.id
Backup dei contatti dello studio
- Nome: Bernadeta Eka Noviati, Magister
- Numero di telefono: +62 896-2816-5916
- Email: eka_noviati@stikespantirapih.ac.id
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Nessun intervento: Arm Group 4, Standard Therapy
Participants receive standard care without structured PLB intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Primary Outcome 1: Respiratory Rate
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Scholastica FA Puspasari, Master, STIKes Panti Rapih Yogyakarta
Pubblicazioni e link utili
Pubblicazioni generali
- 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
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Inizio studio (Stimato)
Completamento primario (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie polmonari, ostruttive
- Condizioni patologiche, segni e sintomi
- Malattia polmonare, cronica ostruttiva
- Fenomeni fisiologici circolatori e respiratori
- Meccanica respiratoria
- Respirazione
- Fenomeni fisiologici respiratori
- Inalazione
- Exhalation
Altri numeri di identificazione dello studio
- 0511028601
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
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Protocollo di studio
Identificatore informazioni: scholastica finaCommenti informativi: PLB Ratio
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Set di dati del singolo partecipante
Identificatore informazioni: scholastica_fina@stikespantiraCommenti informativi: In excel formula
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Piano di analisi statistica
Identificatore informazioni: scholastica_fina@stikespantiraCommenti informativi: Interventional (Clinical Trial)
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Modulo di consenso informato
Identificatore informazioni: scholastica_fina@stikespantiraCommenti informativi: PIS and IC
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Carta del comitato di monitoraggio dei dati
Identificatore informazioni: scholastica_fina@stikespantiraCommenti informativi: DMC
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .