Exercise and Cardiac Measures in Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944775
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
Evangelia Kouidi, Aristotle University Of Thessaloniki

Brief Summary:

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 or disease Intervention/treatment
Sudden Cardiac Death Behavioral: Exercise training

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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
Study Start Date : August 2007
Primary Completion Date : May 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: exercise training
10-month exercise training program
Behavioral: Exercise training
10-month exercise training program during hemodialysis sessions
Other Names:
  • Group A
  • group B
No Intervention: controls
usual care sedentary lifestyle

Primary Outcome Measures :
  1. The composite risk score [ Time Frame: at entry and after 10 months ]

Secondary Outcome Measures :
  1. aerobic capacity (VO2peak) [ Time Frame: At entry and after 10 months ]
  2. Left ventricular ejection fraction (EF)- echocardiography [ Time Frame: At entry and after 10 months ]
  3. standard deviation of normal R-R intervals- SDNN (holter monitoring) [ Time Frame: At entry and after 10 months ]
  4. positive T-wave alternans and Late potentials [ Time Frame: At entry and after 10 months ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00944775

Laboratory of Sports Medicine
Thessaloniki, Greece, 546 35
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Principal Investigator: Evangelia J Kouidi, Associate Pr Aristotle University of Thessaloniki, Greece

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Evangelia Kouidi, Professor of Sports Medicine, Aristotle University Of Thessaloniki Identifier: NCT00944775     History of Changes
Other Study ID Numbers: RenalRehab
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Evangelia Kouidi, Aristotle University Of Thessaloniki:
Non-invasive cardiac measures
Exercise trained patients

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden