- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280419
An Investigation of the Effect of Environmental Factors on Respiratory Muscle Endurance Test Results in Healthy Individuals
Study Overview
Status
Conditions
Detailed Description
Respiratory muscles are as vital as the heart and can be susceptible to fatigue under certain conditions. Therefore, evaluation of the performance of respiratory muscles is critical in the event of impaired respiratory function. Respiratory muscle strength and respiratory muscle endurance tests are used for the evaluation of respiratory muscle functions. While measuring respiratory muscle strength provides information about the individual's pulmonary status, it cannot measure respiratory muscle strength. Respiratory muscle strength is the capacity of respiratory muscles to maintain a specific workload over time and is directly related to respiratory muscle fatigue.
Endurance of respiratory muscles can be evaluated by different methods such as sustained maximal ventilation, increased threshold load test, and fixed threshold load test, and there is no consensus on the best test.
Respiratory muscle fatigue in healthy individuals is known to complicate exercise performance. Fatigue of the respiratory muscles causes the accumulation of metabolites such as lactic acid in the muscles. In this case, the inspiratory respiratory muscle is activated in metaboreflexia; The firing frequency of afferent nerve fibers (type III and IV) increases. An increase in sympathetic stimulation causes general vasoconstriction. Exercise performance is adversely affected. This results in earlier termination of the exercise compared to the conditions where respiratory muscle fatigue is prevented. Therefore, it is stated that reducing or delaying metaboreflex may be an essential mechanism to improve exercise performance.
During general endurance exercise tests, it may be possible to change the environmental aspects (auditory stimuli, listen to motivational music, adjust the tempo with the metronome, give visual feedback, etc.) to suppress metaboreflexia and delay fatigue. It has been shown that listening to music during exercise reduces fatigue and reduces the perception of exercise in healthy individuals.
A possible explanation underlying the beneficial effects of sensory stimuli during exercise involves the integration of multiple physiological systems. In such cases, the attention and emotional effects of sensory stimuli can spread throughout the body by modulating pulmonary, cardiac, hormonal, and muscle systems. Although there are studies about the effects of music on healthy people during whole-body endurance exercises, the effect of music on respiratory muscle endurance was not investigated.
Therefore, this study aims to investigate the effect of music on respiratory muscle endurance test results.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06230
- Recruiting
- Hacettepe University
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Contact:
- Caner Acartürk, MSc
- Phone Number: +905365620203
- Email: acarturkcaner@gmail.com
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Contact:
- Deniz İNAL İNCE, PhD
- Phone Number: +90 312 3051577-148
- Email: dince@hacettepe.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being 18-35 years old.
- Volunteer to participate in the study.
- Without any health problems.
- To be cooperative with the tests to be done.
Exclusion Criteria:
- To have an orthopedic, neurological, chronic cardiovascular, pulmonary, and systemic disease to prevent the tests from being performed.
- To have a visual, auditory, or cognitive problem.
- Not willing to participate in the study.
- To have previous experience in music and instruments used in the study.
- In the last three months, there is no history of exercise training.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healty Subjects
Healthy Subjects Twenty-five healthy individuals will be included in the study.
Physical properties of cases will be recorded.
Respiratory functions and respiratory muscle strength will be evaluated.
Physical activity will be assessed using the International Physical Activity Survey (IPAQ).
Respiratory muscle endurance will be evaluated using an incremental workload test and fixed threshold load test.
Tests will be repeated three times as motivational music, slow-paced music, and music.
Heart rate, respiratory frequency, perceived exertion will be evaluated before and after the test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle endurance test
Time Frame: 1st 2 days
|
Primary Outcome Measure: 1.Respiratory muscle endurance test In our study, the muscle endurance test at the fixed threshold load with 24-hour intervals, and the muscle endurance test at the increased threshold load will be performed. Test times will be calculated and calculated in seconds. The result values will be obtained by multiplying the test time and the pressure value corresponding to the time. In the fixed threshold load, the respiratory muscle endurance test will be performed in 60% of the MIP. For testing, the nose will be closed with a clip after the device is placed in the mouth. The respiratory muscle endurance test will be started with 20% of the MIP in the increased threshold load. The pressure will be increased to 40%, 60%, 80%, and 100% respectively in two minutes intervals. The pressure change and the measurements made in this order shall be made without removing the device from the mouth. For testing, the nose will be closed with a clip after the device is placed. |
1st 2 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GO 19/71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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