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Post-Exercise Hypotension in Elderly Hypertensive Men (HPE)

29. maj 2018 opdateret af: Hospital de Clinicas de Porto Alegre

Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial

The purpose of this study is to compare the effects of two exercise protocols on post-exercise blood pressure versus a control group in elderly hypertensive men. Participants are allocated to all groups: control group and two experimental exercise protocols, in a random order. In the control group, participants remain resting sitting, and, in the exercise protocols, participants practice exercise bouts of aerobic exercise or a combination of resistance and aerobic exercises. In order to standardize baseline conditions, before the sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol, participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5 minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP monitoring is installed in every participant.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period.

Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects.

The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order:

  • Aerobic training session
  • Combined resistance training and aerobic session
  • Control session

After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90035-903
        • Hospital de Clínicas de Porto Alegre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Essential hypertension grade 1 - 2 with or without medical treatment:

resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg

Exclusion Criteria:

  • Smoking;
  • Bone, joint, or muscle problems that could limit the performance of the exercises.
  • BMI ≥ 30 kg/m2
  • Heart Attack in the last year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aerobic exercise
Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.
Andet: Aerobic exercise
Aerobic exercise on treadmill
Eksperimentel: Combined exercises
A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.
Andet: Combined exercises
Combined resistance and aerobic exercise
Sham-komparator: Control
Participants do not exercise and remain sitting for 45 minutes
Andet: Control
45 minutes resting sitting

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ambulatory Blood Pressure Monitoring
Tidsramme: 24 hours
Ambulatory blood pressure monitoring following experimental protocols
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Office Blood Pressure
Tidsramme: 1 hour
Post exercise blood pressure during 60 minutes after experimental sessions
1 hour

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clinicas de Porto Alegre

Samarbejdspartnere

Federal University of Rio Grande do Sul

Efterforskere

  • Ledende efterforsker: Sandra C Fuchs, PhD, Hospital de Clínicas de Porto Alegre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

9. april 2015

Først indsendt, der opfyldte QC-kriterier

13. april 2015

Først opslået (Skøn)

14. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2018

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 130484

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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