Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Aerobic Physical Training and Heart Rate Variability in Hypertersion

21. februar 2017 oppdatert av: Taís Mendes de Camargo, University of Campinas, Brazil

EFFECT OF AEROBIC PHYSICAL TRAINING WITH DETERMINED INTENSITY FOR THE PROTOCOL OF DOUBLE EXHAUSTIVE EFFORTS IN THE AUTONOMICAL MODULATION OF THE HEART FREQUENCY OF PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION

This study compared the changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the protocol of double non-exhaustive efforts (DENE) with that of patients who received routine outpatient care 12 weeks after Entry into the study. 63 men and women participated in the study and were allocated in the intervention group (n = 42) and control group (n = 21).The following were performed: Cardiopulmonary exercise test (TECP) for evaluation of peak oxygen consumption (VO2peak), oxygen pulse and double product; DENE protocol for the determination of the intensity of the training. It was obtained the recording of the intervals between consecutive heart beats (iRR) to evaluate the autonomic modulation of the heart rate. Body mass index, waist circumference (AC), hip circumference (CQ) and Waist / hip ratio (WHR) were measured.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study was designed to compare changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study.

Sixty-three hypertensive men and women, divided into the intervention group (GI) (n=42) and the control group (n = 21) participated in the study.

All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic.

After agreeing to participate in the study, we collected sociodemographic and clinical data, body mass index (BMI), waist circumference (WC) and waist / hip ratio (WHR). The participants were submitted to the cardiopulmonary exercise test (TECP), to evaluate the peak oxygen consumption (VO2peak), oxygen pulse and double product. Between one and seven days after TECP, consecutive heart rate intervals (iRR) were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX (Polar Electro Co.Ltda Kempele, Finland). . The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill. Intervention participants underwent supervised aerobic physical training at the pre-determined intensity, which consisted of three weekly sessions, lasting one hour, over a period of 12 weeks. Control participants receive routine care from the outpatient clinic for the same period. At the end of the 12 weeks, measures, recording of the iRR intervals, oxygen pulse, double product, BMI, waist circumference (AC), hip circumference (QC) and waist / hip ratio (WHR) were obtained. All subjects were previously informed about the procedures Signed a free and informed consent form. The project was approved by the Commission of Research Committee of the Institution with the number 086.096 / 14.

Studietype

Intervensjonell

Registrering (Faktiske)

63

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • SBP ≤ 180 mmHg and DBP ≤ 110 mmHg)
  • low risk for physical training.

Exclusion Criteria:

  • obesity III
  • musculoskeletal conditions
  • peripheral neuropathy
  • Parkinson's disease.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Physical training program

Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks.

All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
Atferdsmessig: Physical training program
Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks. and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility
Atferdsmessig: Physical training program
All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
Ingen inngripen: Control Group
Control participants receive routine outpatient care for a 12-week period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.
Tidsramme: Finalized study (12 weeks)
A heart rate meter RS800CX (Polar Electro Co.Ltda. Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals. The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded
Finalized study (12 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Tidsramme: Finalized study (12 weeks)
Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
Finalized study (12 weeks)
The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Tidsramme: Finalized study (12 weeks)
Cardiopulmonary exercise test used to determine double produc to exercise .
Finalized study (12 weeks)
The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Tidsramme: Finalized study (12 weeks)
Cardiopulmonary exercise test used to determine oxigen pulse to exercise .
Finalized study (12 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Campinas, Brazil

Samarbeidspartnere

Medical Outpatient Vlinic of the Government of the State of São Paulo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. november 2014

Primær fullføring (Faktiske)

21. desember 2015

Studiet fullført (Faktiske)

16. januar 2017

Datoer for studieregistrering

Først innsendt

19. februar 2017

Først innsendt som oppfylte QC-kriteriene

21. februar 2017

Først lagt ut (Faktiske)

27. februar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 865.096

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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. .

Kliniske studier på Physical training program

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Jamaica

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere