Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2019
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedStudy Start
First participant enrolled
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedApril 8, 2019
April 1, 2019
3 months
December 18, 2018
April 4, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
Change from Baseline at 15 minutes
Secondary Outcomes (16)
Maximal inspiratory pressure
At Baseline
Maximal expiratory pressure
At Baseline
Blood pressure
Change from Baseline at 15 minutes
Forced vital capacity
At Baseline
Vital capacity
At Baseline
- +11 more secondary outcomes
Study Arms (4)
Diaphragmatic breathing
EXPERIMENTALDiaphragmatic breathing exercise for 15 minutes.
10% inspiratory muscle training
EXPERIMENTALInspiratory muscle training at 10% intensity of maximal inspiratory pressure for 15 minutes
30% inspiratory muscle training
EXPERIMENTALInspiratory muscle training at 30% intensity of maximal inspiratory pressure for 15 minutes
60% inspiratory muscle training
EXPERIMENTALInspiratory muscle training at 60% intensity of maximal inspiratory pressure for 15 minutes
Interventions
Inspiratory muscle training with a device
Diaphragmatic breathing exercise
Eligibility Criteria
You may qualify if:
- Healthy People
You may not qualify if:
- Body mass index (BMI) \> 30 kg/m²
- Smoking
- The presence of exercise habit
- Medication use
- Neurological, cardiovascular or respiratory disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylül University
Izmir, 35320, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 32851483DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 27, 2018
Study Start
January 2, 2019
Primary Completion
April 4, 2019
Study Completion
April 4, 2019
Last Updated
April 8, 2019
Record last verified: 2019-04