Exercise and Cardiac Measures in Dialysis Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sudden Cardiac Death |
Behavioral: Exercise training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Screening |
| Official Title: | Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial |
- The composite risk score [ Time Frame: at entry and after 10 months ] [ Designated as safety issue: No ]
- aerobic capacity (VO2peak) [ Time Frame: At entry and after 10 months ] [ Designated as safety issue: No ]
- Left ventricular ejection fraction (EF)- echocardiography [ Time Frame: At entry and after 10 months ] [ Designated as safety issue: No ]
- standard deviation of normal R-R intervals- SDNN (holter monitoring) [ Time Frame: At entry and after 10 months ] [ Designated as safety issue: No ]
- positive T-wave alternans and Late potentials [ Time Frame: At entry and after 10 months ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: exercise training
10-month exercise training program
|
Behavioral: Exercise training
10-month exercise training program during hemodialysis sessions
Other Names:
|
| No Intervention: control |
Behavioral: Exercise training
10-month exercise training program during hemodialysis sessions
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Greece | |
| Laboratory of Sports Medicine | |
| Thessaloniki, Greece, 546 35 | |
| Principal Investigator: | Evangelia J Kouidi, Associate Pr | Aristotle University of Thessaloniki, Greece |
More Information
No publications provided by Aristotle University Of Thessaloniki
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Evangelia Kouidi, Cardiologist, Associate Professor of Sports Medicine, Laboratory of Sports Medicine, Aristotle University of Thessaloniki, Greece |
| ClinicalTrials.gov Identifier: | NCT00944775 History of Changes |
| Other Study ID Numbers: | RenalRehab |
| Study First Received: | April 9, 2009 |
| Last Updated: | July 22, 2009 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by Aristotle University Of Thessaloniki:
|
Exercise Dialysis Non-invasive cardiac measures Exercise trained patients Controls |
Additional relevant MeSH terms:
|
Death, Sudden, Cardiac Death Heart Arrest Heart Diseases |
Cardiovascular Diseases Death, Sudden Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013