NCT03788356

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

December 18, 2018

Last Update Submit

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

EXPERIMENTAL

Diaphragmatic breathing exercise for 15 minutes.

Other: Diaphragmatic breathing

10% inspiratory muscle training

EXPERIMENTAL

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

Device: Inspiratory muscle training

30% inspiratory muscle training

EXPERIMENTAL

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

Device: Inspiratory muscle training

60% inspiratory muscle training

EXPERIMENTAL

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

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training with a device

10% inspiratory muscle training30% inspiratory muscle training60% inspiratory muscle training

Diaphragmatic breathing exercise

Also known as: Exercise
Diaphragmatic breathing

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

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.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations