COPDNCT07435532
Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPD
A study testing breather device and incentive spirometer in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- breather device and incentive spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemodynamically unstable patients
- Patients with other cardiorespiratory and neurological diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Riphah International University
Lahore, Punjab Province
Wajeeha Zia, phd, 03234500788, wajeeha.zia@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- COPD
- Being tested
- breather device, incentive spirometer
- Keywords
- COPD, breather device, incentive spirometer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breather deviceDevice
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.
incentive spirometerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| breather device | Active comparator | 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. Receives: Device: breather device |
| incentive spirometer | Experimental | 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. Receives: Other: incentive spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council (mMRC) Dyspnea Scale
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.
Measured: 1st day
Spirometry using a calibrated incentive spirometer:
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
Measured: 1st day
COPD Assessment Test (CAT)
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.
Measured: 1st day
6 Minute Walk Test (6MWT): To evaluate exercise tolerance.
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
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Zia, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435532
- Sponsor's protocol ID
- Tabinda Jabeen
- Other IDs
- 64229, 64229
- Status last verified
- May 2026
- First submitted
- 22 Feb 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsayed, M., et al. (2025).
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Breather Device and Incentive Spirometer on Dyspnea , Lung Function Tests and Quality of Life in Patients With Copd.
- ClinicalTrials.gov ID
- NCT07435532
- Acronym / sponsor ID
- Tabinda Jabeen
- Conditions
- COPD
- Keywords
- COPD, breather device, incentive spirometer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breather device | Active comparator | Device: breather devicePatient 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. |
| incentive spirometer | Experimental | Other: incentive spirometerThe 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Hemodynamically unstable patients
- Patients with other cardiorespiratory and neurological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breather devicePatient 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 |
| incentive spirometerThe 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 |
Primary outcome
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.
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
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- BackgroundElsayed, M., et al. (2025).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wajeeha Zia, phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breather device and incentive spirometer in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wajeeha Zia, phd (03234500788, wajeeha.zia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medical Research Council (mMRC) Dyspnea Scale (time frame: 1st day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.