NCT03200483

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 23, 2017

Last Update Submit

June 26, 2017

Conditions

Keywords

Autonomic Nervous SystemAerobic exerciseRecuperationMusic

Outcome Measures

Primary Outcomes (7)

  • Music effects on heart rate variability based on time domain

    90 minutes

  • Music effects on heart rate variability based on frequency domain

    90 minutes

  • Music effects on heart rate variability based on Chaos domain

    90 minutes

  • Blood pressure (mmHg)

    90 minutes

  • Heart rate (beats per minute)

    90 minutes

  • Respiratory rate (per minute)

    90 minutes

  • Oxygen saturation pulse (SpO2)

    90 minutes

Study Arms (3)

Control Protocol

EXPERIMENTAL

The volunteer will perform the exercise and recovery exposed to silence

Other: Control Protocol

Classical Music Protocol

EXPERIMENTAL

The volunteer will perform the exercise and recovery exposed to classical music

Other: Classical Music Protocol

Rock Music Protocol

EXPERIMENTAL

The volunteer will perform the exercise and recovery exposed to rock musical style

Other: Rock Music Protocol

Interventions

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.

Control Protocol

Volunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery.

Classical Music Protocol

Volunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery.

Rock Music Protocol

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Luiz Carlos Marques Vanderlei, ph.D

    Universidade Estadual Paulista - UNESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 27, 2017

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

June 1, 2015

Last Updated

June 27, 2017

Record last verified: 2017-06