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| Name | Class |
|---|---|
| STIKes Panti Rapih Yogyakarta | OTHER |
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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
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 (SpOâ‚‚), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Group 1, PLB I:E 1:3 | Experimental | Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration) |
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| Arm Group 2, PLB I:E 1:4 | Experimental | Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration) |
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| Arm Group 3, PLB I:E 1:5 | Experimental | Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration) |
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| Arm Group 4, Standard Therapy | No Intervention | Participants receive standard care without structured PLB intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome 1: Respiratory Rate | 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 (SpOâ‚‚) | Peripheral oxygen saturation measured using a calibrated pulse oximeter at rest. | Baseline and immediately after 10-minute intervention |
| Primary Outcome 3 Dyspnea Level | Dyspnea assessed using the Modified Borg Scale (0-10), where higher scores indicate more severe breathlessness. | Baseline and immediately after 10-minute intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scholastica Fina Aryu Puspasari, Master | Contact | +62821-3433-1244 | scholastica_fina@stikespantirapih.ac.id | |
| Bernadeta Eka Noviati, Magister | Contact | +62 896-2816-5916 | eka_noviati@stikespantirapih.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Scholastica FA Puspasari, Master | STIKes Panti Rapih Yogyakarta | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40314858 | Background | Abu-Odah H, Xian-Liang Liu, Wang T, Zhao IY, Yorke J, Tan JB, Molassiotis A. 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. Support Care Cancer. 2025 May 2;33(5):442. doi: 10.1007/s00520-025-09474-x. | |
| Background | 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 | ||
| Background | 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 |
| Label | URL |
|---|---|
| PLB Protocol | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| scholastica fina | Study Protocol | View IPD |
IPD will not be shared because the study involves human participants and the data are subject to institutional and ethical restrictions that limit public data sharing. Only aggregated results will be reported.
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This study uses a parallel assignment interventional model in which participants with stable Chronic Obstructive Pulmonary Disease (COPD) are randomly allocated to one of four groups: three intervention groups and one control group. Each intervention group receives the same type of behavioral intervention-pursed-lip breathing (PLB)-but with different inspiratory-expiratory (I:E) ratios (1:3, 1:4, and 1:5), while the control group receives standard care without structured PLB.
The study follows a pretest-posttest design, where outcome measures are assessed at baseline and immediately after a single 10-minute intervention session. There is no crossover between groups, and each participant is exposed to only one assigned condition throughout the study.
The intervention is administered in a controlled clinical setting with participants in a standardized high-Fowler position to ensure consistency. All groups are observed during the same time frame, and outcome assessments are conducted us
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| Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration) | Other | 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. |
|
| Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration) | Other | 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. |
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| 39477355 | Background | Burge AT, Gadowski AM, Jones A, Romero L, Smallwood NE, Ekstrom M, Reinke LF, Saggu R, Wijsenbeek M, Holland AE. Breathing techniques to reduce symptoms in people with serious respiratory illness: a systematic review. Eur Respir Rev. 2024 Oct 30;33(174):240012. doi: 10.1183/16000617.0012-2024. Print 2024 Oct. |
| 37339502 | Background | Bhatt SP, Nakhmani A, Fortis S, Strand MJ, Silverman EK, Sciurba FC, Bodduluri S. FEV1/FVC Severity Stages for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 15;208(6):676-684. doi: 10.1164/rccm.202303-0450OC. |
| Background | 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 |
PLB Ratio |
| scholastica_fina@stikespantira | Individual Participant Data Set | View IPD | In excel formula |
| scholastica_fina@stikespantira | Statistical Analysis Plan | View IPD | Interventional (Clinical Trial) |
| scholastica_fina@stikespantira | Informed Consent Form | View IPD | PIS and IC |
| scholastica_fina@stikespantira | Data Monitoring Committee Charter | View IPD | DMC |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| D045853 | Exhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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