Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPD

May 5, 2026 updated by: Riphah International University

Comparative Effects of Breather Device and Incentive Spirometer on Dyspnea , Lung Function Tests and Quality of Life in Patients With Copd.

Chronic obstructive pulmonary disease (COPD) is characterized and defined by limitation of expiratory airflow. This can result from several types of anatomical lesions, including loss of lung elastic recoil and fibrosis and narrowing of small airways. Inflammation, edema, and secretions also contribute variably to airflow limitation.it is a preventable and treatable disease characterized by persistent airflow limitation and respiratory symptoms, leading to cough, dyspnea, muscle weakness and fatigue affecting overall well-being and quality of life. The Breather is a respiratory muscle training device strengthening both inspiratory and expiratory muscles by breathing against a set resistance, which can be increased in line with training progress while. Another technique with proven effect in improvement of respiratory function and lung expansion is the incentive spirometry. incentive spirometry is used to encourage deep breathing and effective coughing, to achieve maximum dilation of the bronchi and prevent and treat pulmonary complications such as atelectasis in COPD patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This research of randomized clinical trial will evaluate the effects of breather device and incentive spirometer on dyspnea, lung function and quality of life in COPD patients by taking sample of 80 patients through non probability convenience sampling as per inclusion criteria. The patients will be allocated randomly into two groups. One group will receive breather device 2 sets of 10 breaths two times a day ,6 days a week for 2 weeks. While second group will receive incentive spirometer 20 minutes per session 30 breaths per set 5-6 times a day for 2 weeks. The patient will be asked to hold breath in for 2-3 seconds. Outcomes including Modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT) and 6-minute walk distance will be assessed at baseline and after the intervention period. The data will be analyzed by using SPSS

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 (Estimated)

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.
80

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 Contact

Study Contact

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Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Riphah International University
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both male and female of age group between 45 to 65.
  • Patients with mild to moderate COPD
  • Patients willing to participate.
  • patients with ability to understand and follow the instructions.

Exclusion Criteria:

  • Hemodynamically unstable patients
  • Patients with other cardiorespiratory and neurological diseases.

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: Double

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.
Active Comparator: breather device
Patient will assume a comfortable sitting position on chair; all limbs are rested and supported. The training begins using breather device with the easiest inhalation and exhalation resistances by rotating both the dials to number one. Each patient will be taught and trained to secure the mouthpiece with lips. A soft nose clip will be put on nose to occlude the nostrils and prevent air leaks. each patient will be asked to rapidly inhale, maintained a pause for two to three seconds and then quickly and forcefully exhale. The patient's stomach, rib cage, and neck muscles will be noticed and monitored during breathing in against resistance to make sure to relax the upper chest and shoulders. Then will ask the patient to exhale forcefully for two to three seconds while preventing puffing from the cheeks. The previous steps will be done for 2 sets of ten breaths two times per day, 6 days a week.
Device: breather device
Patient will assume a comfortable sitting position on chair; all limbs are rested and supported. The training begins using breather device with the easiest inhalation and exhalation resistances by rotating both the dials to number one. Each patient will be taught and trained to secure the mouthpiece with lips. A soft nose clip will be put on nose to occlude the nostrils and prevent air leaks. each patient will be asked to rapidly inhale, maintained a pause for two to three seconds and then quickly and forcefully exhale. The patient's stomach, rib cage, and neck muscles will be noticed and monitored during breathing in against resistance to make sure to relax the upper chest and shoulders. Then will ask the patient to exhale forcefully for two to three seconds while preventing puffing from the cheeks. The previous steps will be done for 2 sets of ten breaths two times per day, 6 days a week.
Experimental: incentive spirometer
The preparation and positioning instructions for patients will be given to lose any tight clothing. ensure comforted position and explain treatment concisely. The patients will be asked to take a deep slow inspiration while lips fitted around mouthpiece of incentive spirometer. Visual feedback will be provided to the patient, such as a ball rising to a preset marker, to motivate them during the exercise. The patient will be instructed to get the planned flow at the preset amount. Then patient will be asked to maintain breathing in for 2-3 seconds.
Other: incentive spirometer
The preparation and positioning instructions for patients will be given to lose any tight clothing. ensure comforted position and explain treatment concisely. The patients will be asked to take a deep slow inspiration while lips fitted around mouthpiece of incentive spirometer. Visual feedback will be provided to the patient, such as a ball rising to a preset marker, to motivate them during the exercise. The patient will be instructed to get the planned flow at the preset amount. Then patient will be asked to maintain breathing in for 2-3 seconds.

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
Modified Medical Research Council (mMRC) Dyspnea Scale
Time Frame: 1st day
is a simple questionnaire used to assess the impact of breathlessness on daily activities. It's a 5-point scale ranging from Grade 1 (no breathlessness except with strenuous exercise) to Grade 5 (too breathless to leave the house). The scale is widely used to measure perceived respiratory disability and is valuable in evaluating the severity of breathlessness in various conditions like COPD.
1st day
Spirometry using a calibrated incentive spirometer:
Time Frame: 1st day
An incentive spirometer is a handheld device used to help patients take slow, deep breaths, improving lung function and preventing complications like pneumonia, especially after surgery or illness. It encourages the lungs to expand and strengthen, and can also help clear mucus from the airways
1st day
COPD Assessment Test (CAT)
Time Frame: 1st day
is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how these changes over time. It covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts, including physical activity, confidence, sleep, and energy.
1st day
6 Minute Walk Test (6MWT): To evaluate exercise tolerance.
Time Frame: 1st day
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The object of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway. Six minutes is a long time to walk.. You are permitted to slow down, to stop, and to rest as necessary. You may lean against the wall while resting, but resume walking as soon as you are able. You will be walking back and forth around the cones
1st day

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.
Riphah International 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.
  • Principal Investigator: Wajeeha Zia, phd, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Elsayed, M., et al. (2025).

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 (Estimated)

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.
May 10, 2026

Primary Completion (Estimated)

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.
August 10, 2026

Study Completion (Estimated)

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.
August 10, 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).
February 22, 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.
February 25, 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.
February 27, 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.
May 6, 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.
May 5, 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.
May 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.
  • Tabinda Jabeen
  • 64229 (Other Identifier: Riphah)

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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