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Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

2. november 2012 opdateret af: National Taiwan University Hospital

Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation

Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with increased vagal tone. Patients with AF have poor exercise capacity that may contribute to decreased atrial effective refractory period, and decreased cardiac output and heart rate reserve, and may result in poor quality of life. Poor endothelial function had been noted in patients with AF, associated with increased risks of cerebrovascular and cardiovascular disease. Exercise training has been noted to improve exercise capacity and quality of life in patients with AF only in some studies. Endothelial function can be improved by exercise training in patients with cardiovascular disease, but no report in patients with AF. Evidence of exercise training is still needed in patients with AF. The purpose of this study is to investigate the effect of exercise training on

  1. endothelial function
  2. heart rate variability
  3. exercise capacity
  4. quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A randomized controlled study was implemented to examine :(1) the effect of interval aerobic exercise training combined with resistance training on endothelial function, heart rate variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors related to exercise capacity, and the relationship between exercise capacity and quality of life in patients with permanent atrial fibrillation (AF).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

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

40 år til 76 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Permanent atrial fibrillation≥ 1 year aged 40-76 years
  • Recurrence AF after ablation
  • Under antiarrhythmia medication control

Exclusion Criteria:

  • CAD or myocardial infrarction history
  • NYHA≥ III-IV, or LVEF≤45%
  • Mitral or aortic valve regurgitation ≥ Gr. II
  • Mitral valve or aortic valve stenosis
  • Pacemaker
  • Cardioversion by ablation
  • Pulmonary artery hypertension
  • Any surgery in previous 3 months
  • Any neurological disorders
  • Cancer
  • Severe musculoskeletal disorder
  • Hyperthyroidism
  • Premenopausal women

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise training
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Andet: Exercise training
Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Andre navne:
  • Aerobic exercise Training
Ingen indgriben: control group
Control group conducted the usual care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of exercise capacity (after intervention)
Tidsramme: At baseline and 12 weeks after intervention
To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system
At baseline and 12 weeks after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of heart rate variability (after intervention)
Tidsramme: At baseline and 12 weeks after intervention
To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
At baseline and 12 weeks after intervention
Change values of head up tilt test (after intervention)
Tidsramme: At baseline and 12 weeks after intervention
Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.
At baseline and 12 weeks after intervention
Change of endothelial function (after intervention)
Tidsramme: At baseline and 12 weeks after intervention
To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
At baseline and 12 weeks after intervention
Change of quality of life (after intervention)
Tidsramme: At baseline and 12 weeks after intervention
To measure quality of life by Short-form 36 and symptom checklist
At baseline and 12 weeks after intervention

Samarbejdspartnere og efterforskere

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

Sponsor

National Taiwan University Hospital

Efterforskere

  • Ledende efterforsker: Ying-Tai Wu, phD, National Taiwan University Hospital

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. november 2010

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

22. november 2010

Først indsendt, der opfyldte QC-kriterier

2. november 2012

Først opslået (Skøn)

6. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201010032R

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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