HealthyNCT04280419
An Investigation of the Effect of Environmental Factors on Respiratory Muscle Endurance Test Results in Healthy Individuals
An observational study of Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of music as an environmental factor on respiratory muscle endurance in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Subjects
Who may be able to join
- Being 18-35 years old.
- Volunteer to participate in the study.
- Without any health problems.
- To be cooperative with the tests to be done.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06230
Caner Acartürk, MSc, +905365620203, acarturkcaner@gmail.com
Deniz İNAL İNCE, PhD, +90 312 3051577-148, dince@hacettepe.edu.tr
About this study
This study aims to investigate the effect of music as an environmental factor on respiratory muscle endurance in healthy individuals.
Read the 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.
- Conditions
- Healthy
- Keywords
- Motivational Music, respiratory muscle endurance, perceived exertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle endurance test
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.
Measured: 1st 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start28 Feb 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Acartürk, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280419
- Sponsor's protocol ID
- GO 19/71
- Status last verified
- Feb 2020
- First submitted
- 29 May 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effect of Environmental Factors on Respiratory Muscle Endurance Test Results in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04280419
- Acronym / sponsor ID
- GO 19/71
- Conditions
- Healthy
- Keywords
- Motivational Music, respiratory muscle endurance, perceived exertion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of music as an environmental factor on respiratory muscle endurance in healthy individuals.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Subjects
Key inclusion criteria (4 listed)
- Being 18-35 years old.
- Volunteer to participate in the study.
- Without any health problems.
- To be cooperative with the tests to be done.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caner Acartürk, MSc (+905365620203, acarturkcaner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle endurance test (time frame: 1st 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.