NCT07573826

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Aug 2026

First Submitted

Initial submission to the registry

April 30, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Pursed-Lip Breathing I:E ratio in COPDOxygen saturationdyspnea scalerespiratory rate

Outcome Measures

Primary Outcomes (3)

  • 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 (SpO₂)

    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

Study Arms (4)

Arm Group 1, PLB I:E 1:3

EXPERIMENTAL

Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration)

Other: Participants perform PLB with inspiratory-expiratory ratio 1:3 (2 seconds inspiration, 6 seconds expiration)

Arm Group 2, PLB I:E 1:4

EXPERIMENTAL

Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration)

Other: Participants perform PLB with inspiratory-expiratory ratio 1:4 (2 seconds inspiration, 8 seconds expiration)

Arm Group 3, PLB I:E 1:5

EXPERIMENTAL

Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration)

Other: Participants perform PLB with inspiratory-expiratory ratio 1:5 (2 seconds inspiration, 10 seconds expiration)

Arm Group 4, Standard Therapy

NO INTERVENTION

Participants receive standard care without structured PLB intervention

Interventions

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

Arm Group 1, PLB I:E 1:3

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.

Arm Group 2, PLB I:E 1:4

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.

Arm Group 3, PLB I:E 1:5

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with stable COPD
  • Age ≥ 40 years
  • Able to follow breathing instructions
  • Willing to participate and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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

    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

    BACKGROUND
  • 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

    BACKGROUND
  • 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/

    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

    BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

InhalationExhalation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Scholastica FA Puspasari, Master

    STIKes Panti Rapih Yogyakarta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scholastica Fina Aryu Puspasari, Master

CONTACT

Bernadeta Eka Noviati, Magister

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ns.,M.Kep

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

August 7, 2026

Study Completion (Estimated)

August 14, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

Study Protocol (scholastica fina)Access
Individual Participant Data Set (scholastica_fina@stikespantira)Access
Statistical Analysis Plan (scholastica_fina@stikespantira)Access
Informed Consent Form (scholastica_fina@stikespantira)Access
Data Monitoring Committee Charter (scholastica_fina@stikespantira)Access