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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Music effects on heart rate variability based on time domain
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Music effects on heart rate variability based on frequency domain
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Music effects on heart rate variability based on Chaos domain
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Blood pressure (mmHg)
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Heart rate (beats per minute)
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Respiratory rate (per minute)
Tijdsspanne: 90 minutes
|
90 minutes
|
|
Oxygen saturation pulse (SpO2)
Tijdsspanne: 90 minutes
|
90 minutes
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Luiz Carlos Marques Vanderlei, ph.D, Universidade Estadual Paulista - UNESP
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2200/11
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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