Effectiveness of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease

June 9, 2026 updated by: Chairul Huda, Indonesia University

This study aims to determine the effect of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients with Chronic Obstructive Pulmonary Disease. The main question it aims to answer is:

1. What is the effect of balloon blowing breathing exercise on peripheral oxygen saturation in Chronic Obstructive Pulmonary Disease patients? Participants performed the exercise on the day agreed upon with the researcher. Respondents performed balloon-blowing breathing exercises twice daily for 7 days. These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles. Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times. Oxygen saturation was measured after the intervention on the seventh day to assess the effect of the exercise on peripheral oxygen saturation.

Researchers compared the intervention and control groups to determine whether there was a significant difference between respondents who performed deep breathing exercises and balloon-blowing (intervention) and those who performed only deep breathing exercises (control).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research process was guided by the CONSORT Statement for RCTs. The process involved registration, allocation, follow-up, and analysis. The recruitment process began with a feasibility assessment for potential respondents. This process was carried out when the patient conducted a phase 2 pulmonary rehabilitation evaluation.

Researchers initially reviewed patient data through medical records, reviewing ID, color code, age, gender, medical history, patient condition, and location of residence. Patients' communication skills were assessed during the evaluation.

The inclusion criteria for this study were patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent. Exclusion criteria included patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention. The collected respondents were then randomly assigned using envelopes, dividing them into two groups: 23 respondents in the intervention group and 23 respondents in the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Special Region of Aceh
      • Banda Aceh, Special Region of Aceh, Indonesia, 32126
        • dr. Zainoel Abidin Regional General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent.

Exclusion Criteria:

  • Patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Performed Balloon-blowing and Deep breathing exercises
Behavioral: Balloon-blowing and Deep breathing exercises
Respondents performed balloon-blowing breathing exercises twice daily for 7 days. These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles. Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times.
Experimental: Control Group
Performed only deep breathing exercises
Behavioral: Deep breathing exercises
The participants performed deep breathing exercises twice daily for 7 days. The exercises consisted of three cycles of deep breathing only per session, with a 1-minute rest interval between cycles. Each cycle included a deep breath in for 3-4 seconds, a breath hold for 2-3 seconds, and a slow exhalation for 5-8 seconds, repeated four times.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peripheral Oxygen Saturation
Time Frame: Day 1 & Day 7
Peripheral oxygen saturation was measured using a Braun brand pulse oximeter after the intervention on the first and seventh days to assess the effect of the exercise.
Day 1 & Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chairul Huda, Master & Postgraduate Program, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 770/Litbang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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