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Clinical Trials/NCT03788356
NCT03788356CompletedNot Applicable

Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People

Dokuz Eylul University1 site in 1 country36 target enrollmentStarted: January 2, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Heart Rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy People

Exclusion Criteria

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

Arms & Interventions

Diaphragmatic breathing

Experimental

Diaphragmatic breathing exercise for 15 minutes.

Intervention: Diaphragmatic breathing (Other)

10% inspiratory muscle training

Experimental

Inspiratory muscle training at 10% intensity of maximal inspiratory pressure for 15 minutes

Intervention: Inspiratory muscle training (Device)

30% inspiratory muscle training

Experimental

Inspiratory muscle training at 30% intensity of maximal inspiratory pressure for 15 minutes

Intervention: Inspiratory muscle training (Device)

60% inspiratory muscle training

Experimental

Inspiratory muscle training at 60% intensity of maximal inspiratory pressure for 15 minutes

Intervention: Inspiratory muscle training (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Forced vital capacity(At Baseline)
  • Vital capacity(At Baseline)
  • Forced expiratory volume in 1 second(At Baseline)
  • International Physical Activity Questionnaire(At Baseline)
  • Fatigue level(Change from Baseline at 15 minutes)
  • Dyspnea level(Change from Baseline at 15 minutes)
  • Percentage Of Successive N-N Intervals With A Difference of Duration Longer Than 50 ms(Change from Baseline at 15 minutes)
  • Low Frequency Power(Change from Baseline at 15 minutes)
  • High Frequency Power(Change from Baseline at 15 minutes)
  • Low Frequency/High Frequency ratio(Change from Baseline at 15 minutes)
  • Total Power(Change from Baseline at 15 minutes)
  • Pulse Transit Time(Change from Baseline at 15 minutes)
  • Standard Deviation of Normal to Normal R-R Intervals(Change from Baseline at 15 minutes)
  • Maximal inspiratory pressure(At Baseline)
  • Maximal expiratory pressure(At Baseline)
  • Blood pressure(Change from Baseline at 15 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Buse Ozcan Kahraman

Principal Investigator

Dokuz Eylul University

Study Sites (1)

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