- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Music effects on heart rate variability based on time domain
Tidsramme: 90 minutes
|
90 minutes
|
|
Music effects on heart rate variability based on frequency domain
Tidsramme: 90 minutes
|
90 minutes
|
|
Music effects on heart rate variability based on Chaos domain
Tidsramme: 90 minutes
|
90 minutes
|
|
Blood pressure (mmHg)
Tidsramme: 90 minutes
|
90 minutes
|
|
Heart rate (beats per minute)
Tidsramme: 90 minutes
|
90 minutes
|
|
Respiratory rate (per minute)
Tidsramme: 90 minutes
|
90 minutes
|
|
Oxygen saturation pulse (SpO2)
Tidsramme: 90 minutes
|
90 minutes
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Luiz Carlos Marques Vanderlei, ph.D, Universidade Estadual Paulista - UNESP
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2200/11
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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