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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03200483
Other study ID # 2200/11
Secondary ID
Status Completed
Phase N/A
First received June 23, 2017
Last updated June 26, 2017
Start date March 2014
Est. completion date June 2015

Study information

Verified date June 2017
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 parameters and in the cardiac autonomic response.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 2015
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Control Protocol
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 Protocol
Volunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery.
Rock Music Protocol
Volunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type Measure Description Time frame Safety issue
Primary Music effects on heart rate variability based on time domain 90 minutes
Primary Music effects on heart rate variability based on frequency domain 90 minutes
Primary Music effects on heart rate variability based on Chaos domain 90 minutes
Primary Blood pressure (mmHg) 90 minutes
Primary Heart rate (beats per minute) 90 minutes
Primary Respiratory rate (per minute) 90 minutes
Primary Oxygen saturation pulse (SpO2) 90 minutes
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