Clinical trial NCT03788356: Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People
Official title: Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Healthy People

Exclusion Criteria:

* Body mass index (BMI) \> 30 kg/m²
* Smoking
* The presence of exercise habit
* Medication use
* Neurological, cardiovascular or respiratory disorders

Primary outcomes:
measure: Heart Rate
timeFrame: Change from Baseline at 15 minutes
measure: Augmentation Index
timeFrame: Change from Baseline at 15 minutes
measure: Aortic Pulse Wave Velocity
timeFrame: Change from Baseline at 15 minutes
measure: Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals
timeFrame: Change from Baseline at 15 minutes
Secondary outcomes:
measure: Maximal inspiratory pressure
timeFrame: At Baseline
measure: Maximal expiratory pressure
timeFrame: At Baseline
measure: Blood pressure
timeFrame: Change from Baseline at 15 minutes
measure: Forced vital capacity
timeFrame: At Baseline
measure: Vital capacity
timeFrame: At Baseline
measure: Forced expiratory volume in 1 second
timeFrame: At Baseline
measure: International Physical Activity Questionnaire
timeFrame: At Baseline
measure: Fatigue level
timeFrame: Change from Baseline at 15 minutes
measure: Dyspnea level
timeFrame: Change from Baseline at 15 minutes
measure: Percentage Of Successive N-N Intervals With A Difference of Duration Longer Than 50 ms
timeFrame: Change from Baseline at 15 minutes
measure: Low Frequency Power
timeFrame: Change from Baseline at 15 minutes
measure: High Frequency Power
timeFrame: Change from Baseline at 15 minutes
measure: Low Frequency/High Frequency ratio
timeFrame: Change from Baseline at 15 minutes
measure: Total Power
timeFrame: Change from Baseline at 15 minutes
measure: Pulse Transit Time
timeFrame: Change from Baseline at 15 minutes
measure: Standard Deviation of Normal to Normal R-R Intervals
timeFrame: Change from Baseline at 15 minutes
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
References:
citation: 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.