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
  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

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • The composite risk score [ Time Frame: at entry and after 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Group A
  • group B
No Intervention: control Behavioral: Exercise training
10-month exercise training program during hemodialysis sessions
Other Names:
  • Group A
  • group B

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944775

Locations
Greece
Laboratory of Sports Medicine
Thessaloniki, Greece, 546 35
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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 July 22, 2014