Autonomic Nervous SystemNCT03200483
Musical Auditory Stimulation and Exercise
A study testing Classical Music Protocol and Rock Music Protocol in people with Autonomic Nervous System and Cardiorespiratory Parameters, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
Check the effects of musical auditory stimulation on the autonomic modulation and cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical music can increase recovery velocity after exercise and rock style music can generate a delay in the recovery velocity of the cardiorespiratory… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System, Cardiorespiratory Parameters
- What is being tested?
- Classical Music Protocol and Rock Music Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- Smokers, alcoholics, subjects with cardiovascular, respiratory and neurological disorders known or other pathological conditions that prevented the achievement of protocols will be excluded from the study.
About this study
Official title: Effects of Musical Auditory Stimulation on Autonomic Cardiac Response and Cardiorespiratory Parameters During and After Long-term Submaximal Aerobic Exercise
Check the effects of musical auditory stimulation on the autonomic modulation and cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical music can increase recovery velocity after exercise and rock style music can generate a delay in the recovery velocity of the cardiorespiratory parameters and in the cardiac autonomic response.
Read the detailed description
To implement the experimental protocol, all volunteers were informed to not ingest alcoholic or caffeine-based drinks for 12 hours before the experimental procedure; consuming light meal only two hours before and avoid any vigorous physical exertion 24 hours before the testing.
The experimental procedures were divided into three segments, all performed on a treadmill, with a minimum interval of 48 hours between them in order to allow the volunteers to recover. The protocols running time was always set between 5:30 PM and 9:30 PM, to avoid circadian influences. In addition to these, temperature was fixed between 23 ° C and 24 ° C and humidity between 60% and 70%.
Before the first phase of the experimental protocol the volunteers were approved and the investigators obtained body mass by means of a digital scale (Plenna, TIN 00139 Maxima, Brazil) then height, by means of a stadiometer (ES 2020 - Sanny, Brazil). The comparable stages of the experimental protocol were undertaken:
- Maximal exercise test: the investigators undertook this to record the maximum velocity (Vmax) reached by the volunteer. This was then applied to indirectly determine the anaerobic threshold via the Conconi threshold. Intensity of 60% of the Vmax obtained in the test was lesser than that found in the anaerobic threshold, and this intensity was enforced to perform subsequent steps;
II) Control Protocol (CP): In this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers.
III) Music Protocol (MP): Volunteers accomplished the same activities of the CP, but with exposure to musical auditory stimulation during exercise and recovery.
- Being tested
- Control Protocol, Classical Music Protocol, Rock Music Protocol
- Keywords
- Autonomic Nervous System, Aerobic exercise, Recuperation, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ProtocolOther
In this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers.
Classical Music ProtocolOther
Volunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery.
Rock Music ProtocolOther
Volunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery.
| Study group | Role | What they receive |
|---|---|---|
| Control Protocol | Experimental | The volunteer will perform the exercise and recovery exposed to silence Receives: Other: Control Protocol |
| Classical Music Protocol | Experimental | The volunteer will perform the exercise and recovery exposed to classical music Receives: Other: Classical Music Protocol |
| Rock Music Protocol | Experimental | The volunteer will perform the exercise and recovery exposed to rock musical style Receives: Other: Rock Music Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Music effects on heart rate variability based on time domain
Measured: 90 minutes
Music effects on heart rate variability based on frequency domain
Measured: 90 minutes
Music effects on heart rate variability based on Chaos domain
Measured: 90 minutes
Blood pressure (mmHg)
Measured: 90 minutes
Heart rate (beats per minute)
Measured: 90 minutes
Respiratory rate (per minute)
Measured: 90 minutes
Oxygen saturation pulse (SpO2)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startMar 2014
- Primary completionAug 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos Marques Vanderlei, ph.D, Principal investigator, Universidade Estadual Paulista - UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200483
- Sponsor's protocol ID
- 2200/11
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Musical Auditory Stimulation on Autonomic Cardiac Response and Cardiorespiratory Parameters During and After Long-term Submaximal Aerobic Exercise
- ClinicalTrials.gov ID
- NCT03200483
- Acronym / sponsor ID
- 2200/11
- Keywords
- Autonomic Nervous System, Aerobic exercise, Recuperation, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jun 2017 (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.
Check the effects of musical auditory stimulation on the autonomic modulation and cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical music can increase recovery velocity after exercise and rock style music can generate a delay in the recovery velocity of the cardiorespiratory parameters and in the cardiac autonomic response.
Detailed description
To implement the experimental protocol, all volunteers were informed to not ingest alcoholic or caffeine-based drinks for 12 hours before the experimental procedure; consuming light meal only two hours before and avoid any vigorous physical exertion 24 hours before the testing.
The experimental procedures were divided into three segments, all performed on a treadmill, with a minimum interval of 48 hours between them in order to allow the volunteers to recover. The protocols running time was always set between 5:30 PM and 9:30 PM, to avoid circadian influences. In addition to these, temperature was fixed between 23 ° C and 24 ° C and humidity between 60% and 70%.
Before the first phase of the experimental protocol the volunteers were approved and the investigators obtained body mass by means of a digital scale (Plenna, TIN 00139 Maxima, Brazil) then height, by means of a stadiometer (ES 2020 - Sanny, Brazil). The comparable stages of the experimental protocol were undertaken:
- Maximal exercise test: the investigators undertook this to record the maximum velocity (Vmax) reached by the volunteer. This was then applied to indirectly determine the anaerobic threshold via the Conconi threshold. Intensity of 60% of the Vmax obtained in the test was lesser than that found in the anaerobic threshold, and this intensity was enforced to perform subsequent steps;
II) Control Protocol (CP): In this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers.
III) Music Protocol (MP): Volunteers accomplished the same activities of the CP, but with exposure to musical auditory stimulation during exercise and recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Protocol | Experimental | Other: Control ProtocolThe volunteer will perform the exercise and recovery exposed to silence |
| Classical Music Protocol | Experimental | Other: Classical Music ProtocolThe volunteer will perform the exercise and recovery exposed to classical music |
| Rock Music Protocol | Experimental | Other: Rock Music ProtocolThe volunteer will perform the exercise and recovery exposed to rock musical style |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- Smokers, alcoholics, subjects with cardiovascular, respiratory and neurological disorders known or other pathological conditions that prevented the achievement of protocols will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control ProtocolIn this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers. | Other | Control Protocol |
| Classical Music ProtocolVolunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery. | Other | Classical Music Protocol |
| Rock Music ProtocolVolunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery. | Other | Rock Music Protocol |
Primary outcome
Music effects on heart rate variability based on time domain
Time frame: 90 minutes
Music effects on heart rate variability based on frequency domain
Time frame: 90 minutes
Music effects on heart rate variability based on Chaos domain
Time frame: 90 minutes
Blood pressure (mmHg)
Time frame: 90 minutes
Heart rate (beats per minute)
Time frame: 90 minutes
Respiratory rate (per minute)
Time frame: 90 minutes
Oxygen saturation pulse (SpO2)
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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.
Luiz Carlos Marques Vanderlei, ph.D principal investigator
Universidade Estadual Paulista - UNESP
Questions about this trial
What is this clinical trial studying?
A study testing Classical Music Protocol and Rock Music Protocol in people with Autonomic Nervous System and Cardiorespiratory Parameters, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Music effects on heart rate variability based on time domain (time frame: 90 minutes). The study lists 7 primary outcomes in all. 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 27 Jun 2017.