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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training
Diaphragmatic breathing
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Diaphragmatic breathing

10% inspiratory muscle training

30% inspiratory muscle training

60% inspiratory muscle training

Arm Description

Diaphragmatic breathing exercise for 15 minutes.

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 18, 2018
Last Updated
April 4, 2019
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03788356
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic breathing
Arm Type
Experimental
Arm Description
Diaphragmatic breathing exercise for 15 minutes.
Arm Title
10% inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training at 10% intensity of maximal inspiratory pressure for 15 minutes
Arm Title
30% inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training at 30% intensity of maximal inspiratory pressure for 15 minutes
Arm Title
60% inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training at 60% intensity of maximal inspiratory pressure for 15 minutes
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Inspiratory muscle training with a device
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing
Other Intervention Name(s)
Exercise
Intervention Description
Diaphragmatic breathing exercise
Primary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Augmentation Index
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Aortic Pulse Wave Velocity
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Square Root of The Mean Squared Difference of Successive Normal to Normal R-R Intervals
Description
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.
Time Frame
Change from Baseline at 15 minutes
Secondary Outcome Measure Information:
Title
Maximal inspiratory pressure
Description
Assessment of maximal inspiratory pressure with an electronic mouth pressure device (Micro; Micro Medical Ltd., Rochester, UK). Higher values indicate stronger inspiratory muscle strength.
Time Frame
At Baseline
Title
Maximal expiratory pressure
Description
Assessment of maximal expiratory pressure with an electronic mouth pressure device (Micro; Micro Medical Ltd., Rochester, UK). Higher values indicate stronger expiratory muscle strength.
Time Frame
At Baseline
Title
Blood pressure
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Forced vital capacity
Description
Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame
At Baseline
Title
Vital capacity
Description
The vital capacity is the volume of air a subject is able to expire after a maximal inspiration to the total lung capacity.
Time Frame
At Baseline
Title
Forced expiratory volume in 1 second
Description
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.
Time Frame
At Baseline
Title
International Physical Activity Questionnaire
Description
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.
Time Frame
At Baseline
Title
Fatigue level
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Dyspnea level
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Percentage Of Successive N-N Intervals With A Difference of Duration Longer Than 50 ms
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Low Frequency Power
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
High Frequency Power
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Low Frequency/High Frequency ratio
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Total Power
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Pulse Transit Time
Description
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.
Time Frame
Change from Baseline at 15 minutes
Title
Standard Deviation of Normal to Normal R-R Intervals
Description
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.
Time Frame
Change from Baseline at 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dokuz Eylül University
City
Izmir
ZIP/Postal Code
35320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32851483
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. Erratum In: Ir J Med Sci. 2020 Sep 9;:
Results Reference
derived

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

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