HealthyNCT07029074
Investigation of Inspiratory Muscle Training Applied at Different Intensities on Intercostal Muscle Oxygenation
A study testing MIP 30% inspiratory muscle training and MIP 70% inspiratory muscle training in people with Healthy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to investigate the acute effect of inspiratory muscle training of different intensities on intercostal muscle oxygenation in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Healthy
- What is being tested?
- MIP 30% inspiratory muscle training and MIP 70% inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2025to 15 Jun 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physically active (doing moderate intensity physical activity for at least 3 days a week for 150 minutes / week)
- Volunteer to participate in the study
Who cannot join
- Healthy individuals with any diagnosed chronic or systemic disease,
- Smoke 10 packs x years or more,
- Pneumonia or any acute infection,
- Psychiatric disorder will excluded in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit
Kırşehir
About this study
Official title: Investigation of the Acute Effect of Inspiratory Muscle Training Applied at Different Intensities on Intercostal Muscle Oxygenation
In this study, it was aimed to investigate the acute effect of inspiratory muscle training of different intensities on intercostal muscle oxygenation in healthy individuals.
Read the detailed description
The functional activity of the respiratory system must be regular and efficient in order to meet the oxygen needs of tissues and organs. The mechanical function of the respiratory system is significantly related to the working capacity of the respiratory muscles. The diaphragm is the primary muscle that provides respiratory functions among the respiratory muscles.The external intercostal muscles help with the inspiration, while the internal intercostal muscles help with the expiration. The basis of inspiratory muscle training is to reduce dyspnea, increase inspiratory muscle function and exercise tolerance. Inspiratory muscle training provides an increase in muscle strength by increasing inspiratory muscle strength, reducing metaboreflex activity and increasing blood flow to the muscles. Training is thought to minimize the effects of activation of inspiratory muscle metaboreflex in both healthy individuals and patients with heart failure. In chronic respiratory patients, forced inspiration effort reduces capillary perfusion of the respiratory muscles, thus increasing the oxygen demand of the muscle. Muscle oxygen saturation shows the oxygen uptake and oxygen consumption of the muscle. It aims to investigate the mechanisms involved in the metaboreflex response to respiratory fatigue in inspiratory muscle training, which severity will acutely reduce it more.
- Conditions
- Healthy
- Being tested
- Sham inspiratory muscle training (MIP 0%), MIP 30% inspiratory muscle training, MIP 70% inspiratory muscle training
- Keywords
- muscle oxygenation, inspiratory muscle training, intercostal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham inspiratory muscle training (MIP 0%)Device
POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.
MIP 30% inspiratory muscle trainingDevice
POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.
MIP 70% inspiratory muscle trainingOther
POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Sham inspiratory muscle training (Maximal inspiratory pressure (MIP) 0%) | Experimental | Individuals participating in the study will be randomly assigned sham inspiratory muscle training sessions maximal inspiratory pressure of 0% under the supervision of a specialist physiotherapist for 15 minutes. Receives: Device: Sham inspiratory muscle training (MIP 0%) |
| MIP 30% inspiratory muscle training | Experimental | Individuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 30% under the supervision of a specialist physiotherapist for 15 minutes. Receives: Device: MIP 30% inspiratory muscle training |
| MIP 70% inspiratory muscle training | Experimental | Individuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 70% under the supervision of a specialist physiotherapist for 15 minutes. Receives: Other: MIP 70% inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of intercostal muscle oxygenation
Before the inspiratory muscle training sessions, the muscle oxygen saturation (SmO2) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Measured: Second, Third and Fourth day
Evaluation of intercostal muscle total hemoglobin level
Before the inspiratory muscle training sessions, total hemoglobin level (THb) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Measured: Second, Third and Fourth day
Secondary outcomes (3)
Evaluation of respiratory muscle strength
An electronic mouth pressure device will be used to evaluate respiratory muscle strength. Patients will have maximal inspiratory pressure and maximal expiratory pressure measured with a mouth pressure measuring device.
Measured: First day
Evaluation of respiratory muscle endurance
The incremental threshold loading test will be used to evaluate respiratory muscle endurance. The PowerBreathe Wellness® (HaB International Ltd. Southam, UK) will be used in the incremental threshold loading test.
Measured: First day
Evaluation of physical activity level
The physical activity level of individuals will be evaluated using the short form of the International Physical Activity Questionnaire. A score is obtained by multiplying the metabolic equivalent (MET) value by days and minutes. When calculating the walking score, the walking time will be multiplied by 3.3 METs; when calculating the moderate intensity activity score, it will be multiplied by 4 METs; when calculating the vigorous activity score, it will be multiplied by 8 METs. Physical activity levels will be classified as physically inactive (3000 MET-min/week).
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start24 Jul 2025
- Primary completion20 May 2026
- Study completion15 Jun 2026
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 Kirsehir Ahi Evran UniversitesiThe 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
- Crossover
- Model description
- This study was designed as a single-blind randomized, placebo-controlled, crossover study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak KAVALCI KOL, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029074
- Sponsor's protocol ID
- AhiEvranU529
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be stored in a locked cabinet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effect of Inspiratory Muscle Training Applied at Different Intensities on Intercostal Muscle Oxygenation
- ClinicalTrials.gov ID
- NCT07029074
- Acronym / sponsor ID
- AhiEvranU529
- Conditions
- Healthy
- Keywords
- muscle oxygenation, inspiratory muscle training, intercostal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 19 Jun 2025 (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.
In this study, it was aimed to investigate the acute effect of inspiratory muscle training of different intensities on intercostal muscle oxygenation in healthy individuals.
Detailed description
The functional activity of the respiratory system must be regular and efficient in order to meet the oxygen needs of tissues and organs. The mechanical function of the respiratory system is significantly related to the working capacity of the respiratory muscles. The diaphragm is the primary muscle that provides respiratory functions among the respiratory muscles.The external intercostal muscles help with the inspiration, while the internal intercostal muscles help with the expiration. The basis of inspiratory muscle training is to reduce dyspnea, increase inspiratory muscle function and exercise tolerance. Inspiratory muscle training provides an increase in muscle strength by increasing inspiratory muscle strength, reducing metaboreflex activity and increasing blood flow to the muscles. Training is thought to minimize the effects of activation of inspiratory muscle metaboreflex in both healthy individuals and patients with heart failure. In chronic respiratory patients, forced inspiration effort reduces capillary perfusion of the respiratory muscles, thus increasing the oxygen demand of the muscle. Muscle oxygen saturation shows the oxygen uptake and oxygen consumption of the muscle. It aims to investigate the mechanisms involved in the metaboreflex response to respiratory fatigue in inspiratory muscle training, which severity will acutely reduce it more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study was designed as a single-blind randomized, placebo-controlled, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Sham inspiratory muscle training (Maximal inspiratory pressure (MIP) 0%) | Experimental | Device: Sham inspiratory muscle training (MIP 0%)Individuals participating in the study will be randomly assigned sham inspiratory muscle training sessions maximal inspiratory pressure of 0% under the supervision of a specialist physiotherapist for 15 minutes. |
| MIP 30% inspiratory muscle training | Experimental | Device: MIP 30% inspiratory muscle trainingIndividuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 30% under the supervision of a specialist physiotherapist for 15 minutes. |
| MIP 70% inspiratory muscle training | Experimental | Other: MIP 70% inspiratory muscle trainingIndividuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 70% under the supervision of a specialist physiotherapist for 15 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically active (doing moderate intensity physical activity for at least 3 days a week for 150 minutes / week)
- Volunteer to participate in the study
Key exclusion criteria (4 listed)
- Healthy individuals with any diagnosed chronic or systemic disease,
- Smoke 10 packs x years or more,
- Pneumonia or any acute infection,
- Psychiatric disorder will excluded in the study.
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 |
|---|---|---|
| Sham inspiratory muscle training (MIP 0%)POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training. | Device | Sham inspiratory muscle training (Maximal inspiratory pressure (MIP) 0%) |
| MIP 30% inspiratory muscle trainingPOWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training. | Device | MIP 30% inspiratory muscle training |
| MIP 70% inspiratory muscle trainingPOWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training. | Other | MIP 70% inspiratory muscle training |
Primary outcome
Evaluation of intercostal muscle oxygenation
Time frame: Second, Third and Fourth day
Before the inspiratory muscle training sessions, the muscle oxygen saturation (SmO2) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Evaluation of intercostal muscle total hemoglobin level
Time frame: Second, Third and Fourth day
Before the inspiratory muscle training sessions, total hemoglobin level (THb) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
3 secondary outcomes
Evaluation of respiratory muscle strength
Time frame: First day
Evaluation of respiratory muscle endurance
Time frame: First day
Evaluation of physical activity level
Time frame: First day
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 20 Jul 2026.
- Individual participant dataSharing planned: No. Data will be stored in a locked cabinet.
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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 MIP 30% inspiratory muscle training and MIP 70% inspiratory muscle training in people with Healthy, run by Kirsehir Ahi Evran Universitesi 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 4 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 20 Jul 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 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?
Evaluation of intercostal muscle oxygenation (time frame: Second, Third and Fourth day). 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 20 Jul 2026.