HealthyNCT03788356
Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People
A study testing Inspiratory muscle training and Diaphragmatic breathing in people with Healthy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inspiratory muscle training and Diaphragmatic breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 4 Apr 2019
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy People
Who cannot join
- Body mass index (BMI) > 30 kg/m²
- Smoking
- The presence of exercise habit
- Medication use
- Neurological, cardiovascular or respiratory disorders
Trial locations and contacts
1 site in 1 country.
About this study
At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.
Read the detailed description
Cardiovascular diseases are the leading cause of mortality in developed and developing countries and constitute a significant morbidity burden for life. Cardiovascular diseases risk factors include obesity, lipid profile, unhealthy diet, sedentary lifestyle, high blood pressure, increased arteriosclerosis.
Although aerobic exercise is recommended as exercise modality to reduce cardiovascular risk, the effects of resistant exercise on cardiovascular health are not clear. In addition, regular aerobic and resistant exercise regulate cardiac autonomic function.
Inspiratory muscle training is a time-efficient, well-tolerated and safe approach for both healthy people and people with chronic diseases. Long-term inspiratory muscle training has been shown to increase respiratory muscle strength and decrease blood pressure in healthy individuals. One-session inspiratory muscle training has been shown to improve autonomic function in smokers and older individuals. However, the effects of different intensities of inspiratory muscle training on blood pressure, autonomic function, and arterial stiffness in healthy young people are not fully understood. For these reasons, the aim of the study is to investigate the acute effects of inspiratory muscle training at different intensities in healthy people.
At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.
- Conditions
- Healthy
- Being tested
- Inspiratory muscle training, Diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Inspiratory muscle training with a device
Diaphragmatic breathingOther
Also called Exercise
Diaphragmatic breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing | Experimental | Diaphragmatic breathing exercise for 15 minutes. Receives: Other: Diaphragmatic breathing |
| 10% inspiratory muscle training | Experimental | Inspiratory muscle training at 10% intensity of maximal inspiratory pressure for 15 minutes Receives: Device: Inspiratory muscle training |
| 30% inspiratory muscle training | Experimental | Inspiratory muscle training at 30% intensity of maximal inspiratory pressure for 15 minutes Receives: Device: Inspiratory muscle training |
| 60% inspiratory muscle training | Experimental | Inspiratory muscle training at 60% intensity of maximal inspiratory pressure for 15 minutes Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
The heart rate is the number of beats per minute of the heart. It represents both sympathetic and parasympathetic system activity. increased heart rate indicates that the sympathetic activity is dominant, while decreased heart rate indicates that parasympathetic activity is dominant.
Measured: Change from Baseline at 15 minutes
Augmentation Index
Augmentation index is commonly used noninvasive measurements of wave reflection strength. To assess augmentation index, brachial artery compression waveforms were obtained by partially inflating a cuff over the brachial artery approximately midway between the shoulder and the elbow. The brachial waveforms were calibrated using cuff-measured brachial systolic and diastolic pressures, and then used to generate central aortic pressure waveforms by applying proprietary digital signal processing and transfer function. The central aortic pulse wave was used to determine augmentation index. High values represent abnormal wave reflection strength.
Measured: Change from Baseline at 15 minutes
Aortic Pulse Wave Velocity
Aortic pulse wave velocity is commonly used noninvasive measurements of arterial stiffness. To assess aortic pulse wave velocity, carotid pulse waves were measured by applanation tonometry and femoral pulse waves were simultaneously obtained by a partially inflated cuff over the femoral artery at the leg midway between the hip and the knee. Aortic pulse wave velocity was determined by calculating the ratio of the corrected distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. High values represent increased arterial stiffness.
Measured: Change from Baseline at 15 minutes
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals is one of the time domain methods of heart rate variability. It represents a primarily parasympathetic activity or vagal modulation. Low values indicate decreased parasympathetic activity. High values indicate increased parasympathetic activity.
Measured: Change from Baseline at 15 minutes
Secondary outcomes (16)
Maximal inspiratory pressure
Assessment of maximal inspiratory pressure with an electronic mouth pressure device (Micro; Micro Medical Ltd., Rochester, UK). Higher values indicate stronger inspiratory muscle strength.
Measured: At Baseline
Maximal expiratory pressure
Assessment of maximal expiratory pressure with an electronic mouth pressure device (Micro; Micro Medical Ltd., Rochester, UK). Higher values indicate stronger expiratory muscle strength.
Measured: At Baseline
Blood pressure
Brachial and central systolic and diastolic blood pressure. High Brachial and central systolic and diastolic blood pressure are associated with higher risk of heart attacks and strokes, even in people with normal cuff Blood pressure.
Measured: Change from Baseline at 15 minutes
Forced vital capacity
Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: At Baseline
Vital capacity
The vital capacity is the volume of air a subject is able to expire after a maximal inspiration to the total lung capacity.
Measured: At Baseline
Forced expiratory volume in 1 second
The volume of air expired in the first second of expiration or forced expiratory volume in 1 second, especially when expressed as a ratio with the total amount of air expired during the forced vital capacity, is a good index of expiratory airways resistance.
Measured: At Baseline
International Physical Activity Questionnaire
The International Physical Activity Questionnaire short-form measures physical activity. The International Physical Activity Questionnaire short-form occurs 7 items. The higher values indicate better physical activity level. The minimum score of scale was 0, and maximum score is depend on patients activity and there is no maximum score.
Measured: At Baseline
Fatigue level
Fatigue level after the training will be questioned with a 100-mm visual analog scale, minimum 0 to maximum 100. Higher scores indicate higher fatigue levels.
Measured: Change from Baseline at 15 minutes
Dyspnea level
Dyspnea level after the training will be questioned with the modified Borg Scale. Minimum value is 0 (no dyspnea), and maximum value is 10 (maximal dyspnea) Higher scores indicate higher fatigue levels.
Measured: Change from Baseline at 15 minutes
Percentage Of Successive N-N Intervals With A Difference of Duration Longer Than 50 ms
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals is one of the time domain methods of heart rate variability. It represents parasympathetic activity. Low values indicate decreased parasympathetic activity. High values indicate increased parasympathetic activity.
Measured: Change from Baseline at 15 minutes
Low Frequency Power
Low Frequency is one of the frequency domain methods of heart rate variability. Spectral power analysis is performed on a series of R-R intervals which separates the heart rate spectrum into various components and allows the quantification of sympathetic and vagal influences on the heart. Low Frequency range is 0.04-0.15 Hz. Low frequency band represents both sympathetic and parasympathetic modulation.
Measured: Change from Baseline at 15 minutes
High Frequency Power
High Frequency is one of the frequency domain methods of heart rate variability. Spectral power analysis is performed on a series of R-R intervals which separates the heart rate spectrum into various components and allows the quantification of sympathetic and vagal influences on the heart. High Frequency range is 0.15-0.4 Hz. High Frequency band represents parasympathetic modulation. Low values indicate decreased parasympathetic activity. High values indicate increased parasympathetic activity.
Measured: Change from Baseline at 15 minutes
Low Frequency/High Frequency ratio
Low Frequency/High Frequency ratio is one of the frequency domain methods of heart rate variability. Low Frequency/High Frequency ratio is a index of sympathovagal balance. Increased ratio indicates that the sympathetic activity is dominant, while decreased ratio indicates that parasympathetic activity is dominant.
Measured: Change from Baseline at 15 minutes
Total Power
Total Power is one of the frequency domain methods of heart rate variability. It shows general change of autonomic modulation. Low values indicate decreased autonomic modulation. High values indicate increased autonomic modulation.
Measured: Change from Baseline at 15 minutes
Pulse Transit Time
Pulse transit time is the time that takes the pulse pressure wave to travel through the arterial tree. Decreased pulse transit time shows increased wave velocity on the vessels.
Measured: Change from Baseline at 15 minutes
Standard Deviation of Normal to Normal R-R Intervals
Standard Deviation of Normal to Normal R-R Intervals is one of the time domain methods of heart rate variability. Time Domain Analysis measures the change in heart rate over time or the intervals between successive normal cardiac cycles.It assesses globally heart rate variability. Low values indicate decreased heart rate variability. High values indicate increased heart rate variability.
Measured: Change from Baseline at 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start2 Jan 2019
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
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 HealthyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Ozcan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788356
- Sponsor's protocol ID
- 2018/14-16
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tanriverdi A, Kahraman BO, Ozsoy I, Ozpelit E, Savci S. Acute effects of inspiratory muscle training at different intensities in healthy young people. Ir J Med Sci. 2021 May;190(2):577-585. doi: 10.1007/s11845-020-02353-w. Epub 2020 Aug 26.
PubMed 32851483
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People
- ClinicalTrials.gov ID
- NCT03788356
- Acronym / sponsor ID
- 2018/14-16
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 27 Dec 2018 (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.
At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.
Detailed description
Cardiovascular diseases are the leading cause of mortality in developed and developing countries and constitute a significant morbidity burden for life. Cardiovascular diseases risk factors include obesity, lipid profile, unhealthy diet, sedentary lifestyle, high blood pressure, increased arteriosclerosis.
Although aerobic exercise is recommended as exercise modality to reduce cardiovascular risk, the effects of resistant exercise on cardiovascular health are not clear. In addition, regular aerobic and resistant exercise regulate cardiac autonomic function.
Inspiratory muscle training is a time-efficient, well-tolerated and safe approach for both healthy people and people with chronic diseases. Long-term inspiratory muscle training has been shown to increase respiratory muscle strength and decrease blood pressure in healthy individuals. One-session inspiratory muscle training has been shown to improve autonomic function in smokers and older individuals. However, the effects of different intensities of inspiratory muscle training on blood pressure, autonomic function, and arterial stiffness in healthy young people are not fully understood. For these reasons, the aim of the study is to investigate the acute effects of inspiratory muscle training at different intensities in healthy people.
At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing | Experimental | Other: Diaphragmatic breathingDiaphragmatic breathing exercise for 15 minutes. |
| 10% inspiratory muscle training | Experimental | Device: Inspiratory muscle trainingInspiratory muscle training at 10% intensity of maximal inspiratory pressure for 15 minutes |
| 30% inspiratory muscle training | Experimental | Device: Inspiratory muscle trainingInspiratory muscle training at 30% intensity of maximal inspiratory pressure for 15 minutes |
| 60% inspiratory muscle training | Experimental | Device: Inspiratory muscle trainingInspiratory muscle training at 60% intensity of maximal inspiratory pressure for 15 minutes |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy People
Key exclusion criteria (5 listed)
- Body mass index (BMI) > 30 kg/m²
- Smoking
- The presence of exercise habit
- Medication use
- Neurological, cardiovascular or respiratory disorders
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 |
|---|---|---|
| Inspiratory muscle trainingInspiratory muscle training with a device | Device | 10% inspiratory muscle training, 30% inspiratory muscle training, 60% inspiratory muscle training |
| Diaphragmatic breathingAlso: ExerciseDiaphragmatic breathing exercise | Other | Diaphragmatic breathing |
Primary outcome
Heart Rate
Time frame: Change from Baseline at 15 minutes
The heart rate is the number of beats per minute of the heart. It represents both sympathetic and parasympathetic system activity. increased heart rate indicates that the sympathetic activity is dominant, while decreased heart rate indicates that parasympathetic activity is dominant.
Augmentation Index
Time frame: Change from Baseline at 15 minutes
Augmentation index is commonly used noninvasive measurements of wave reflection strength. To assess augmentation index, brachial artery compression waveforms were obtained by partially inflating a cuff over the brachial artery approximately midway between the shoulder and the elbow. The brachial waveforms were calibrated using cuff-measured brachial systolic and diastolic pressures, and then used to generate central aortic pressure waveforms by applying proprietary digital signal processing and transfer function. The central aortic pulse wave was used to determine augmentation index. High values represent abnormal wave reflection strength.
Aortic Pulse Wave Velocity
Time frame: Change from Baseline at 15 minutes
Aortic pulse wave velocity is commonly used noninvasive measurements of arterial stiffness. To assess aortic pulse wave velocity, carotid pulse waves were measured by applanation tonometry and femoral pulse waves were simultaneously obtained by a partially inflated cuff over the femoral artery at the leg midway between the hip and the knee. Aortic pulse wave velocity was determined by calculating the ratio of the corrected distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. High values represent increased arterial stiffness.
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals
Time frame: Change from Baseline at 15 minutes
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals is one of the time domain methods of heart rate variability. It represents a primarily parasympathetic activity or vagal modulation. Low values indicate decreased parasympathetic activity. High values indicate increased parasympathetic activity.
16 secondary outcomes
Maximal inspiratory pressure
Time frame: At Baseline
Maximal expiratory pressure
Time frame: At Baseline
Blood pressure
Time frame: Change from Baseline at 15 minutes
Forced vital capacity
Time frame: At Baseline
Vital capacity
Time frame: At Baseline
Forced expiratory volume in 1 second
Time frame: At Baseline
International Physical Activity Questionnaire
Time frame: At Baseline
Fatigue level
Time frame: Change from Baseline at 15 minutes
Dyspnea level
Time frame: Change from Baseline at 15 minutes
Percentage Of Successive N-N Intervals With A Difference of Duration Longer Than 50 ms
Time frame: Change from Baseline at 15 minutes
Low Frequency Power
Time frame: Change from Baseline at 15 minutes
High Frequency Power
Time frame: Change from Baseline at 15 minutes
Low Frequency/High Frequency ratio
Time frame: Change from Baseline at 15 minutes
Total Power
Time frame: Change from Baseline at 15 minutes
Pulse Transit Time
Time frame: Change from Baseline at 15 minutes
Standard Deviation of Normal to Normal R-R Intervals
Time frame: Change from Baseline at 15 minutes
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 8 Apr 2019.
- Derived from this study: PubMed 32851483Tanriverdi A, Kahraman BO, Ozsoy I, Ozpelit E, Savci S. Acute effects of inspiratory muscle training at different intensities in healthy young people. Ir J Med Sci. 2021 May;190(2):577-585. doi: 10.1007/s11845-020-02353-w. Epub 2020 Aug 26.
- Individual participant dataSharing planned: Undecided
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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 Inspiratory muscle training and Diaphragmatic breathing in people with Healthy, run by Dokuz Eylul 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 1 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 8 Apr 2019. 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?
Heart Rate (time frame: Change from Baseline at 15 minutes). 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 NCT03788356, 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 8 Apr 2019.