HealthyNCT06245928
The Effects of Individualized Respiratory Exercise Device in Healthy Individuals
A study testing Individualized Respiratory Exercise Device and Threshold® IMT + Threshold™ PEP in people with Healthy, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Individualized Respiratory Exercise Device and Threshold® IMT + Threshold™ PEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Answering "No" to the general health questions of the Exercise Readiness Questionnaire for all
Who cannot join
- Being an amateur or professional athlete who does sports-specific training at least 2 times a week
- Having a chronic disease
- Having history of spontaneous or trauma-related pneumothorax
- Having pathologies related to the middle ear (such as tympanic membrane rupture, otitis)
- Receiving routine medical treatment other than vitamin supplements for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals
Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range.
The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.
A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.
- Conditions
- Healthy
- Being tested
- Individualized Respiratory Exercise Device, Threshold® IMT + Threshold™ PEP
- Keywords
- Respiratory Exercise Device, Biomedical Device, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity, Respiratory Muscle Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Respiratory Exercise DeviceDevice
The Individualized Respiratory Exercise device will include both inspiratory muscle training, expiratory muscle training, and intensive spirometer features.
Threshold® IMT + Threshold™ PEPDevice
The Threshold® IMT device allows inspiratory muscle training and the Threshold™ PEP device allows expiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The initial pressure load will be set to the resistance level corresponding to 40% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements. Participants will be asked to rest following 6 breathing cycles and repeat a total of 36 breathing cycles (6 sets) in each session. Participants will be able to practice both inspiratory and expiratory respiratory muscle training in one breathing cycle. Progression will be increased by 5-10% weekly, with the perceived exertion level being in the range of 4-6 according to the Modified Borg Scale. In addition, physical activity will be recommended. Receives: Device: Individualized Respiratory Exercise Device |
| Control Group | Active comparator | The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. Respiratory muscle training will be performed with Threshold® IMT and Threshold™ PEP devices. The training intensity will be set to 40% of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements in the first week. Participants will be asked to perform 6 sets of 6 repetitions for inspiratory and expiratory muscle training separately for a total of 36 repetitions each. Progression will be increased by 5-10% weekly so that the perceived exertion level will be in the range of 4-6 according to the Modified Borg Scale. If the training threshold exceeds the upper-pressure limits of the Threshold® IMT + Threshold™ PEP devices, the training intensity will be continued at the highest limit. In addition, physical activity will be recommended. Receives: Device: Threshold® IMT + Threshold™ PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Measured: 8 weeks
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Measured: 8 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Peak Expiratory Flow (PEF)
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Forced Expiratory Flow 25-75% (FEF25-75)
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8 weeks
Spiropalm 6-minute Walk Test
The 6-minute Walk Test will be performed with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
Measured: 8 weeks
Secondary outcomes (1)
Convenience of Device Use
A 5-point Likert scale will be used to question the convenience of use of the devices used. Scoring will be determined as 1- "very difficult to use", 5- "very easy to use".
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Biruni 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hikmet Ucgun, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245928
- Sponsor's protocol ID
- buhucgun04
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals
- ClinicalTrials.gov ID
- NCT06245928
- Acronym / sponsor ID
- buhucgun04
- Conditions
- Healthy
- Keywords
- Respiratory Exercise Device, Biomedical Device, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 7 Feb 2024 (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.
Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range.
The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.
A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Individualized Respiratory Exercise DeviceThe individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The initial pressure load will be set to the resistance level corresponding to 40% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements. Participants will be asked to rest following 6 breathing cycles and repeat a total of 36 breathing cycles (6 sets) in each session. Participants will be able to practice both inspiratory and expiratory respiratory muscle training in one breathing cycle. Progression will be increased by 5-10% weekly, with the perceived exertion level being in the range of 4-6 according to the Modified Borg Scale. In addition, physical activity will be recommended. |
| Control Group | Active comparator | Device: Threshold® IMT + Threshold™ PEPThe individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. Respiratory muscle training will be performed with Threshold® IMT and Threshold™ PEP devices. The training intensity will be set to 40% of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements in the first week. Participants will be asked to perform 6 sets of 6 repetitions for inspiratory and expiratory muscle training separately for a total of 36 repetitions each. Progression will be increased by 5-10% weekly so that the perceived exertion level will be in the range of 4-6 according to the Modified Borg Scale. If the training threshold exceeds the upper-pressure limits of the Threshold® IMT + Threshold™ PEP devices, the training intensity will be continued at the highest limit. In addition, physical activity will be recommended. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being between the ages of 18-65
- Answering "No" to the general health questions of the Exercise Readiness Questionnaire for all
Key exclusion criteria (5 listed)
- Being an amateur or professional athlete who does sports-specific training at least 2 times a week
- Having a chronic disease
- Having history of spontaneous or trauma-related pneumothorax
- Having pathologies related to the middle ear (such as tympanic membrane rupture, otitis)
- Receiving routine medical treatment other than vitamin supplements for any reason
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 |
|---|---|---|
| Individualized Respiratory Exercise DeviceThe Individualized Respiratory Exercise device will include both inspiratory muscle training, expiratory muscle training, and intensive spirometer features. | Device | Experimental Group |
| Threshold® IMT + Threshold™ PEPThe Threshold® IMT device allows inspiratory muscle training and the Threshold™ PEP device allows expiratory muscle training. | Device | Control Group |
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: 8 weeks
Maximal Inspiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Maximal Expiratory Pressure (MEP)
Time frame: 8 weeks
Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Forced Vital Capacity (FVC)
Time frame: 8 weeks
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Peak Expiratory Flow (PEF)
Time frame: 8 weeks
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Flow 25-75% (FEF25-75)
Time frame: 8 weeks
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Spiropalm 6-minute Walk Test
Time frame: 8 weeks
The 6-minute Walk Test will be performed with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
1 secondary outcome
Convenience of Device Use
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Respiratory Exercise Device and Threshold® IMT + Threshold™ PEP in people with Healthy, run by Biruni University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (MIP) (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.