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The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure

23. oktober 2016 opdateret af: Dr. Robert Klempfner Heart Rehabilitation Institute

The aim of the present study is to evaluate differential lactate removal kinetics in heart failure patients that are trained according to 2 different exercise protocols:

(A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Introduction: Congestive heart failure (CHF) patients suffer from early fatigue and functional aerobic impairment. Their reduced cardiac output and O2 delivery to the peripheral muscles shifts those patients consistent anaerobic metabolism, thus, CHF patients rely on anaerobic metabolism even in everyday life activity. This metabolism leads to a shift of muscles fiber types from mainly slow twitch, oxidative type I fibers to fast twitch, glycolytic type IIb fibers. Monocarboxylate proteins MCT1 and MCT4 transport lactate crosses the membrane. MCT1 is responsible for the lactate uptake and MCT4 is responsible for efflux of excess lactate. Exercise training is known to improve the quality of life in CHF. We hypothesized that exercise training might change MCT1 and 4 expression and distribution. Accordingly, these changes may also affect lactate clearance during recovery, which may contribute to the beneficial effect of exercise training in CHF patients. Methods: New-York Heart association (NYHA) class II-III CHF patients will be assigned to the experiment. At baseline and upon training conclusion they will undergo the same tests battery. The test battery includes heart rate, blood pressure measurements, echocardiographic evaluation. All participants will fill out "Minnesota living with heart failure" questionnaire. Subsequently, after their basal blood lactate will be assessed they will undergo measurement which will be followed by lactate clearance-rate evaluation.

Randomly each patient will then be assigned to one of two experimental training groups: (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT). Each volunteer will be trained twice a week for 12 weeks, according to his/hers assigned training protocol and in accordance to exercise training guidelines.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Israel
      • Tel Hashomer , Ramat Gan, Israel
        • Sheba Medical Center, Cardiac Rehabilitation Institute

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute
  • Age > 21

Exclusion Criteria:

  • Severe symptomatic heart failure
  • Severe orthopedic limitations
  • Unstable arrythmia
  • Cognitive decline or substance abuse
  • Unable to comply with exercise protocol
  • Significant pulmonary disease
  • NYHA 4 heart failure class

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Continues aerobic training
Treadmill or exercise bike training with target heart rate of 50-70% of the heart rate reserve (or 50-60% of the peak VO2 reserve). Overall 45 minutes of exercise (including the 5-10 minute warm-up period).
Andet: Continues aerobic training
Eksperimentel: Interval Exercse Training
Bouts of high intensity interval treadmill or exercise bike training, comprising of 85-95% of the heart rate reserve (or 80-90% of the peak VO2 reserve), for the duration of 4 minutes, separated by periods of low intensity activity until the heart rate reaches 50% of the peak heart rate. This set will be repeated 3 times.
Andet: Interval exercise training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lactate clearance kinetics
Tidsramme: Baseline and following 12 weeks of training
Change from baseline of lactate clearance kinetics followoing a 12 weeks exercise program based on two different training protocol (continues and interval training)
Baseline and following 12 weeks of training

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak VO2 change
Tidsramme: Pre- and post 12 week exercise program
Change from baseline of the peak VO2 following the 12 weeks exercise program
Pre- and post 12 week exercise program

Andre resultatmål

Resultatmål
Tidsramme
Quality of life questioner (MLWHF)
Tidsramme: Pre training and 12 weeks later post exercise training period
Pre training and 12 weeks later post exercise training period

Samarbejdspartnere og efterforskere

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

Sponsor

Dr. Robert Klempfner Heart Rehabilitation Institute

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. februar 2014

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

2. december 2013

Først indsendt, der opfyldte QC-kriterier

8. december 2013

Først opslået (Skøn)

12. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LACT_HF_KIN

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 .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med Continues aerobic training

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Betingelser

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Placeringer

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