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Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients

10. marts 2015 opdateret af: Graciele Sbruzzi, Instituto de Cardiologia do Rio Grande do Sul

Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial

The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The aim of this study is to assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity and quality of life in patients with heart failure (HF). A randomized clinical trial with 60 HF patients (functional class II-IV) will be randomly assigned to the FES, IMT, IMT associated with FES or control group. FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. Acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

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, 90.620-000
        • Rekruttering
        • Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
        • Kontakt:
        • Kontakt:

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:

  • Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
  • Aged 30-70 years
  • Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)

Exclusion Criteria:

  • Patients with unstable heart failure
  • NYHA class I
  • Unstable angina pectoris and ventricular arrhythmia
  • Implanted cardiac pacemaker
  • Acute pulmonary diseases
  • Chronic renal failure or dialysis
  • Acute myocardial infarction 3 months before the inclusion in the study
  • Acute inflammatory diseases
  • Peripheral vascular disease
  • Neurologic disease
  • Musculoskeletal pathologies
  • Malignancies or being an active smoker

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Ingen indgriben.
Eksperimentel: Combined training
Training with functional electrical stimulation added by inspiratory muscle training.
Andet: Kontrolgruppe
Ingen indgriben
Andet: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Andre navne:
  • Elektrisk stimulation
  • Eletric stimulation therapy
Andet: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Andre navne:
  • Breathing exercises
  • Respiratory muscle training
Eksperimentel: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Andet: Kontrolgruppe
Ingen indgriben
Andet: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Andre navne:
  • Breathing exercises
  • Respiratory muscle training
Andet: Combined training
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
Andre navne:
  • Elektrisk stimulation
  • Inspirerende muskeltræning
  • Breathing exercises
Eksperimentel: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Andet: Kontrolgruppe
Ingen indgriben
Andet: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Andre navne:
  • Elektrisk stimulation
  • Eletric stimulation therapy
Andet: Combined training
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
Andre navne:
  • Elektrisk stimulation
  • Inspirerende muskeltræning
  • Breathing exercises

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional capacity
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.
12 weeks
Peripheral muscle strength
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
12 weeks
Pulmonary function
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.
12 weeks
Respiratory muscle strength
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.
12 weeks
Endothelial function
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.
12 weeks
Autonomic control
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.
12 weeks
Oxidative stress
Tidsramme: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Samarbejdspartnere

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Efterforskere

  • Ledende efterforsker: Rodrigo DM Plentz, PhD, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia

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 2010

Primær færdiggørelse (Forventet)

1. marts 2016

Studieafslutning (Forventet)

1. marts 2017

Datoer for studieregistrering

Først indsendt

14. marts 2011

Først indsendt, der opfyldte QC-kriterier

29. marts 2011

Først opslået (Skøn)

30. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UP 4546/10

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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