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Exercise and Cardiac Measures in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00944775
First received: April 9, 2009
Last updated: July 22, 2009
Last verified: June 2009

April 9, 2009
July 22, 2009
August 2007
May 2008   (final data collection date for primary outcome measure)
The composite risk score [ Time Frame: at entry and after 10 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944775 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Sudden Cardiac Death
Behavioral: Exercise training
10-month exercise training program during hemodialysis sessions
Other Names:
  • Group A
  • group B
  • Active Comparator: exercise training
    10-month exercise training program
    Intervention: Behavioral: Exercise training
  • No Intervention: control
    Intervention: Behavioral: Exercise training
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. Epub 2009 Jul 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00944775
RenalRehab
Yes
Dr Evangelia Kouidi, Cardiologist, Associate Professor of Sports Medicine, Laboratory of Sports Medicine, Aristotle University of Thessaloniki, Greece
Aristotle University Of Thessaloniki
Not Provided
Principal Investigator: Evangelia J Kouidi, Associate Pr Aristotle University of Thessaloniki, Greece
Aristotle University Of Thessaloniki
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP