Chronic Obstructive Pulmonary DiseaseNCT06259188
Effectiveness of Personalized Breathing Exercise Device in Patients With COPD
A study testing Respiratory Muscle Training Device and Personalized Breathing Exercise Device in people with Chronic Obstructive Pulmonary Disease and Inspiratory Muscle Training, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Inspiratory Muscle Training, Expiratory Muscle Training
- What is being tested?
- Respiratory Muscle Training Device and Personalized Breathing Exercise Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 29 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD by a pulmonologist according to GOLD 2022 diagnostic criteria (GOLD, 2022) and in classes B, C and D according to GOLD
- Followed for at least 6 months
- Clinically stable patients without exacerbations or infections
Who cannot join
- Patients with a history of spontaneous or trauma-related pneumothorax
- Patients with middle ear-related pathologies (such as tympanic membrane rupture, otitis)
- Orthopedic and neurological problems that may interfere with exercise training
- Changes in medical treatment during the study
- Patients with unstable concomitant cardiac disease
- Patients who have been involved in another pulmonary rehabilitation program within the last 6 months
- Insufficient cooperation
Trial locations and contacts
1 site in 1 country.
Buket Akıncı contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, 34320
Ozge Ertan
About this study
Official title: Investigation of the Effectiveness of Personalized Breathing Exercise Device in Patients With COPD
The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Respiratory muscle training applied to individuals with COPD is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. Although there is sufficient evidence in the literature about the benefits of IMT in individuals with COPD. There is little evidence showing the effects of EMT. Studies show that isolated IMT and EMT are effective in increasing respiratory muscle strength, endurance and exercise capacity. Results from a limited number of studies show that combined training of IMT and EMT is superior compared to isolated IMT or isolated EMT in improving exercise capacity and dyspnea. Incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. In the pulmonary rehabilitation guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. The personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. With the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.
- Conditions
- Chronic Obstructive Pulmonary Disease, Inspiratory Muscle Training, Expiratory Muscle Training
- Being tested
- Respiratory Muscle Training Device, Personalized Breathing Exercise Device
- 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.
Respiratory Muscle Training DeviceDevice
In the both groups the initial pressure load will be set to the resistance level corresponding to the 40% of the MIP and MEP measurement. Participants will be asked to rest following 5 breathing cycles and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. In breathing exercise device group participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. In IMT+EMT group, patients will be able to practice different to device. As the progression progresses, the perceived exertion level will be increased by 5-10% every week, to be in the range of 4-6 according to the Modified Borg scale.
Personalized Breathing Exercise DeviceDevice
Personalized Breathing Exercise Device
| Study group | Role | What they receive |
|---|---|---|
| Personalized Breathing Exercise Device Group | Experimental | In the personalized respiratory exercise device group, the initial pressure load will be set to the resistance level corresponding to 40% of the MIP and MEP measurements. Participants will be asked to rest following 5 breathing cycles and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. As the progression progresses, the perceived exertion level will be increased by 5-10% on a weekly basis, to be in the range of 4-6 according to the Modified Borg scale. Receives: Device: Personalized Breathing Exercise Device |
| Respiratory Muscle Training Group | Active comparator | Respiratory muscle training will be done with Threshold® IMT and Threshold™ PEP devices. Training intensity will be set to 40% of MIP and MEP measurements in the first week. For inspiratory muscle training, participants will be asked to rest after 5 breathing repetitions and repeat the training for 10 sets. Participants will be asked to rest after 5 exhalation repetitions for expiratory muscle training and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. As the progression progresses, the perceived exertion level will be increased by 5-10% on a weekly basis, to be in the range of 4-6 according to the Modified Borg scale. At this point, if the training threshold exceeds the upper pressure limits of Threshold® IMT + Threshold™ PEP devices, the training intensity will continue at the upper limit. Receives: Device: Respiratory Muscle Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal static inspiratory mouth pressure
Measurement will be made with a respiratory muscle strength measuring device. MIP: maximal inspiratory pressure
Measured: 1 week-8 week
Maximal static expiratory mouth pressure
Measurement will be made with a respiratory muscle strength measuring device. MEP: maximal expiratory pressure
Measured: 1 week-8 week
Secondary outcomes (9)
Respiratory Functions FEV1
Pulmonary function test: FEV1 L and %
Measured: 1 week-8 week
Respiratory Functions FVC
Pulmonary function test: FVC L and %
Measured: 1 week-8 week
Respiratory Functions FEV1/FVC
Pulmonary function test: FEV1/FVC%
Measured: 1 week-8 week
Respiratory Functions PEF
Pulmonary function test: PEF L/S and %
Measured: 1 week-8 week
Diffusion Capacity
Pulmonary function test: DLCO%
Measured: 1 week-8 week
Exercise capacity
Spiropalm six minute walk test
Measured: 1 week-8 week
Activities of daily living
London Chest Activities of Daily Living Scale (LCADL): Perceived dyspnea while performing activities of daily living is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum total score 0 and maximum total score is 75.
Measured: 1 week-8 week
Activity Status
Duke Activity Status Index: The Duke Activity Status Index (DASI) is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points
Measured: 1 week-8 week
Device ease of use
5-Likert Scale: Scoring will be determined as 1- "very difficult to use" and 5- "very easy to use".
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start10 Apr 2024
- Primary completion29 May 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University, The Scientific and Technological Research Council of Turkey, Istanbul University
- Responsible party
- Principal investigator, Ozge Ertan, Istanbul University - Cerrahpasa
- Investigators
- Ozge Ertan, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259188
- Sponsor's protocol ID
- 1001
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Personalized Breathing Exercise Device in Patients With COPD
- ClinicalTrials.gov ID
- NCT06259188
- Acronym / sponsor ID
- 1001
- Conditions
- Chronic Obstructive Pulmonary Disease, Inspiratory Muscle Training, Expiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Biruni University, The Scientific and Technological Research Council of Turkey, Istanbul University
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 29 May 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 14 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.
The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Respiratory muscle training applied to individuals with COPD is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. Although there is sufficient evidence in the literature about the benefits of IMT in individuals with COPD. There is little evidence showing the effects of EMT. Studies show that isolated IMT and EMT are effective in increasing respiratory muscle strength, endurance and exercise capacity. Results from a limited number of studies show that combined training of IMT and EMT is superior compared to isolated IMT or isolated EMT in improving exercise capacity and dyspnea. Incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. In the pulmonary rehabilitation guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. The personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. With the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Breathing Exercise Device Group | Experimental | Device: Personalized Breathing Exercise DeviceIn the personalized respiratory exercise device group, the initial pressure load will be set to the resistance level corresponding to 40% of the MIP and MEP measurements. Participants will be asked to rest following 5 breathing cycles and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. As the progression progresses, the perceived exertion level will be increased by 5-10% on a weekly basis, to be in the range of 4-6 according to the Modified Borg scale. |
| Respiratory Muscle Training Group | Active comparator | Device: Respiratory Muscle Training DeviceRespiratory muscle training will be done with Threshold® IMT and Threshold™ PEP devices. Training intensity will be set to 40% of MIP and MEP measurements in the first week. For inspiratory muscle training, participants will be asked to rest after 5 breathing repetitions and repeat the training for 10 sets. Participants will be asked to rest after 5 exhalation repetitions for expiratory muscle training and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. As the progression progresses, the perceived exertion level will be increased by 5-10% on a weekly basis, to be in the range of 4-6 according to the Modified Borg scale. At this point, if the training threshold exceeds the upper pressure limits of Threshold® IMT + Threshold™ PEP devices, the training intensity will continue at the upper limit. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with COPD by a pulmonologist according to GOLD 2022 diagnostic criteria (GOLD, 2022) and in classes B, C and D according to GOLD
- Followed for at least 6 months
- Clinically stable patients without exacerbations or infections
Key exclusion criteria (7 listed)
- Patients with a history of spontaneous or trauma-related pneumothorax
- Patients with middle ear-related pathologies (such as tympanic membrane rupture, otitis)
- Orthopedic and neurological problems that may interfere with exercise training
- Changes in medical treatment during the study
- Patients with unstable concomitant cardiac disease
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 |
|---|---|---|
| Respiratory Muscle Training DeviceIn the both groups the initial pressure load will be set to the resistance level corresponding to the 40% of the MIP and MEP measurement. Participants will be asked to rest following 5 breathing cycles and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. In breathing exercise device group participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. In IMT+EMT group, patients will be able to practice different to device. As the progression progresses, the perceived exertion level will be increased by 5-10% every week, to be in the range of 4-6 according to the Modified Borg scale. | Device | Respiratory Muscle Training Group |
| Personalized Breathing Exercise DevicePersonalized Breathing Exercise Device | Device | Personalized Breathing Exercise Device Group |
Primary outcome
Maximal static inspiratory mouth pressure
Time frame: 1 week-8 week
Measurement will be made with a respiratory muscle strength measuring device. MIP: maximal inspiratory pressure
Maximal static expiratory mouth pressure
Time frame: 1 week-8 week
Measurement will be made with a respiratory muscle strength measuring device. MEP: maximal expiratory pressure
9 secondary outcomes
Respiratory Functions FEV1
Time frame: 1 week-8 week
Respiratory Functions FVC
Time frame: 1 week-8 week
Respiratory Functions FEV1/FVC
Time frame: 1 week-8 week
Respiratory Functions PEF
Time frame: 1 week-8 week
Diffusion Capacity
Time frame: 1 week-8 week
Exercise capacity
Time frame: 1 week-8 week
Activities of daily living
Time frame: 1 week-8 week
Activity Status
Time frame: 1 week-8 week
Device ease of use
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
Buket Akıncı contact
Ozge Ertan principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Training Device and Personalized Breathing Exercise Device in people with Chronic Obstructive Pulmonary Disease and Inspiratory Muscle Training, run by Istanbul University - Cerrahpasa 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozge Ertan (+902124141500, ozge.ertann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal static inspiratory mouth pressure (time frame: 1 week-8 week). The study lists 2 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 8 Oct 2024.