- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200483
Musical Auditory Stimulation and Exercise
Effects of Musical Auditory Stimulation on Autonomic Cardiac Response and Cardiorespiratory Parameters During and After Long-term Submaximal Aerobic Exercise
Study Overview
Status
Intervention / Treatment
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:
I) 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Protocol
The volunteer will perform the exercise and recovery exposed to silence
|
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.
|
Experimental: Classical Music Protocol
The volunteer will perform the exercise and recovery exposed to classical music
|
Volunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery.
|
Experimental: Rock Music Protocol
The volunteer will perform the exercise and recovery exposed to rock musical style
|
Volunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Music effects on heart rate variability based on time domain
Time Frame: 90 minutes
|
90 minutes
|
Music effects on heart rate variability based on frequency domain
Time Frame: 90 minutes
|
90 minutes
|
Music effects on heart rate variability based on Chaos domain
Time Frame: 90 minutes
|
90 minutes
|
Blood pressure (mmHg)
Time Frame: 90 minutes
|
90 minutes
|
Heart rate (beats per minute)
Time Frame: 90 minutes
|
90 minutes
|
Respiratory rate (per minute)
Time Frame: 90 minutes
|
90 minutes
|
Oxygen saturation pulse (SpO2)
Time Frame: 90 minutes
|
90 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luiz Carlos Marques Vanderlei, ph.D, Universidade Estadual Paulista - UNESP
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 2200/11
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.
Clinical Trials on Autonomic Nervous System
-
The Hong Kong Polytechnic UniversityUnknownAutonomic Nervous System DisorderChina
-
Northwell HealthEnrolling by invitationAutonomic Nervous System Diseases | Autonomic Dysfunction | Autonomic Imbalance | Vagus Nerve Autonomic DisorderUnited States
-
Istanbul Medipol University HospitalCompletedVagus Nerve Autonomic DisorderTurkey
-
Virginia Polytechnic Institute and State UniversityNot yet recruiting
-
University of Mississippi Medical CenterVicor Technologies, Inc.CompletedAutonomic DysfunctionUnited States
-
Federal University of Health Science of Porto AlegreCompletedVertebra; Degeneration | Other Disorders of the Autonomic Nervous SystemBrazil
-
National Institute of Neurological Disorders and...Completed
-
Fondazione Don Carlo Gnocchi OnlusCompletedAutonomic Nervous System Disease | Osteopathy
-
University of MichiganCompletedAutonomic Peripheral Nervous System DiseasesUnited States
-
Universidad Autonoma de MadridCentro Universitario La SalleCompleted
Clinical Trials on Control Protocol
-
Jeanne SowersActive, not recruiting
-
Institut GuttmannThe University of QueenslandUnknownBrain Injuries, Traumatic | Alteration of Cognitive Function | Confusional State | Sensory Motor System DisorderSpain
-
Huazhong University of Science and TechnologyWuhan Union Hospital, China; Wuhan No.1 Hospital; The Affiliated Hospital of... and other collaboratorsRecruitingDiminished Ovarian ReserveChina
-
Instituto de Cardiologia do Rio Grande do SulCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; University Hospital... and other collaboratorsNot yet recruitingCongenital Heart Defects | Underweight
-
University of ValenciaCompletedTension-type HeadacheSpain
-
University of ThessalyTerminatedPower Training Exercise ProtocolsGreece
-
University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
-
Luiz Carlos Marques VanderleiCompleted
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed