Exercise and Cardiac Measures in Dialysis Patients
Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial
Background: The impact of the known non-invasive cardiac indices for identification of hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been evaluated.
Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged 54.6±8.9 years) participated in a supervised training program with stationary bicycles during their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years) remained untrained and were used as controls.
Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of SCD and the total score positively.
Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac autonomic nervous system activity evaluation by time- and frequency- domain heart rate variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal exercise test for microvolt-T-wave alternans (TWA) detection.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The identification of patients on hemodialysis (HD) at increased cardiac risk with powerful screening tests and the reduction of factors, which increase the probability of malignant arrhythmias are important for primary prevention of sudden cardiac death (SCD).
Study Design: randomized and controlled clinical trial. Setting & Participants: Fifty-nine HD patients were randomized into exercise training group (group A-30 patients) and controls (group B-29 patients).
Intervention: Group A participated in a 10-month supervised exercise training program during the HD sessions (3/weekly).
Outcomes: The effects of exercise on the score of the non-invasive cardiac markers for SCD risk stratification and on the occurrence of each variable separately. Statistical analysis included a two-group comparison of change scores and an analysis of covariance adjusting for baseline.
Measurements: At entry and the end of the study, in all participants aerobic capacity (VO2peak) and left ventricular ejection fraction (LVEF) were estimated, late potentials and T-wave alternans were detected and heart rate variability was calculated. Specifically, from the 24-h Holter monitoring the standard deviation of all the normal R-R intervals (SDNN), the mean R-R intervals (mean RR), the low (LF) and high (HF) frequency components of the autoregressive power spectrum of the NN intervals and their ratio (LF/HF) were recorded.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Thessaloniki, Hellas, 546 35
- Laboratory of Sports Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- on HD for at least 6 months
- in sinus rhythm
- able to reach a sufficient workload during ergometry
Exclusion Criteria:
- with bundle branch block
- unstable hypertension
- diabetes mellitus
- severe congestive heart failure
- recent myocardial infarction
- unstable angina
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: exercise training
10-month exercise training program
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10-month exercise training program during hemodialysis sessions
Andre navn:
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Ingen inngripen: controls
usual care sedentary lifestyle
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The composite risk score
Tidsramme: at entry and after 10 months
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at entry and after 10 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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aerobic capacity (VO2peak)
Tidsramme: At entry and after 10 months
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At entry and after 10 months
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Left ventricular ejection fraction (EF)- echocardiography
Tidsramme: At entry and after 10 months
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At entry and after 10 months
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standard deviation of normal R-R intervals- SDNN (holter monitoring)
Tidsramme: At entry and after 10 months
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At entry and after 10 months
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positive T-wave alternans and Late potentials
Tidsramme: At entry and after 10 months
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At entry and after 10 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Evangelia J Kouidi, Associate Pr, Aristotle University of Thessaloniki, Greece
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Kouidi EJ, Grekas DM, Deligiannis AP. Effects of exercise training on noninvasive cardiac measures in patients undergoing long-term hemodialysis: a randomized controlled trial. Am J Kidney Dis. 2009 Sep;54(3):511-21. doi: 10.1053/j.ajkd.2009.03.009. Epub 2009 Jul 30.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RenalRehab
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