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
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90.620-000
- Rekruttering
- Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
-
Kontakt:
- Rodrigo DM Plentz, PhD
- Telefonnummer: + 55 51 32192802
- E-mail: roplentz@yahoo.com.br
-
Kontakt:
- Graciele Sbruzzi, MSc
- Telefonnummer: + 55 51 32232746
- E-mail: graci_sbruzzi@hotmail.com
-
-
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.
|
Ingen indgriben
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:
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Andre navne:
|
|
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
|
Ingen indgriben
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Andre navne:
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:
|
|
Eksperimentel: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
|
Ingen indgriben
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:
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:
|
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.
Samarbejdspartnere
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
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 .