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Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension. (TREMVEN)

Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.

The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.

Studieoversigt

Detaljeret beskrivelse

The interaction between respiratory function and cardiovascular system, as well as the present alterations in these systems, due to diseases such as Hypertension, diabetes and chronic heart failure, are the factors that potentially participate of the pathogenic frame in these situations. Consequently, it is so related to reduction of functional capacity, endothelial dysfunction of the sympathetic and parasympathetic cardiovascular control and morphologic alterations on the skeletal muscles, including ventilatory muscles.

On the other hand, a proinflammatory state also participates of this dysfunction and reduced function capacity situation. Cardiovascular risk factors, such as hypertension, increased heart rate variability, diabetes and heart failure explain the occurrence of the majority of cardiovascular events in the entire world and so in Brazil. Studies with experimental models and in patients with cardiovascular diseases identified important inflammatory activity associated to risk factors and preceding clinical events.

Inspiratory muscle training (IMT) shows consistent results in the improvement of functional capacity in athletes, sedentary subjects, heart failure patients and in animals submitted to an IMT model.

The study of alterations in cardiorespiratory interaction, functional capacity and cardiovascular control mechanisms (sympathetic, parasympathetic by heart rate variability), altogether, in hypertension, is a single opportunity to identify new pathogenic mechanisms involved in the reduction of functional capacity as well as promote its quantification. Therefore, the effects of IMT on these alterations are still not well understood. In this way, the response to IMT is a complement to epidemiologic and clinical models, as potential source of new possibilities in the research field.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

14

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • RS
      • Porto Alegre, RS, Brasilien, 90050-170
        • Pedro Dal Lago

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

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age between 25 and 70
  2. Hypertension in all stages:

2.1. Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg

Exclusion Criteria:

  1. Disagreement with consent form
  2. Thoracic pain (angina)
  3. Hypertension instability
  4. Antihypertensive drugs alterations within 30 days before or during the study
  5. Diabetes
  6. Chronic pulmonary obstructive disease
  7. Incapability of executing the functional tests
  8. Asthma
  9. Chronic Heart Failure
  10. Obesity
  11. Cardiovascular diseases complications

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inspiratory Muscle Training
It will me performed a loaded training of ventilatory muscles in patients with Hypertension. Its is done with the practice of breathing exercises associated to an training device, specific for this kind of intervention.
Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences on blood pressure levels
Tidsramme: eight weeks
Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.
eight weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
improvement of Heart rate variability
Tidsramme: eight weeks
eight weeks
improvement of quality of life
Tidsramme: eigth weeks
To measure the quality of life, it is used the SF36 short form questionary.
eigth weeks
Improvement of Functional Capacity
Tidsramme: eight weeks
It is measure by the oxytgen consumption accessed by ergospirometry.
eight weeks

Samarbejdspartnere og efterforskere

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

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 2009

Primær færdiggørelse (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

29. november 2010

Først indsendt, der opfyldte QC-kriterier

29. november 2010

Først opslået (Skøn)

30. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. november 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2010

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

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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