Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2007-08-31
2008-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
TRIPLE
Study Groups
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exercise training
10-month exercise training program
Exercise training
10-month exercise training program during hemodialysis sessions
controls
usual care sedentary lifestyle
No interventions assigned to this group
Interventions
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Exercise training
10-month exercise training program during hemodialysis sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* in sinus rhythm
* able to reach a sufficient workload during ergometry
Exclusion Criteria
* unstable hypertension
* diabetes mellitus
* severe congestive heart failure
* recent myocardial infarction
* unstable angina
18 Years
70 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Evangelia Kouidi
Professor of Sports Medicine
Principal Investigators
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Evangelia J Kouidi, Associate Pr
Role: PRINCIPAL_INVESTIGATOR
Aristotle University of Thessaloniki, Greece
Locations
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Laboratory of Sports Medicine
Thessaloniki, , Greece
Countries
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References
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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.
Other Identifiers
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RenalRehab
Identifier Type: -
Identifier Source: org_study_id