Exercise and Cardiac Measures in Dialysis Patients
Primary Purpose
Sudden Cardiac Death
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional screening trial for Sudden Cardiac Death focused on measuring Exercise, Dialysis, Non-invasive cardiac measures, Exercise trained patients, Controls
Eligibility 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
Sites / Locations
- Laboratory of Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise training
controls
Arm Description
10-month exercise training program
usual care sedentary lifestyle
Outcomes
Primary Outcome Measures
The composite risk score
Secondary Outcome Measures
aerobic capacity (VO2peak)
Left ventricular ejection fraction (EF)- echocardiography
standard deviation of normal R-R intervals- SDNN (holter monitoring)
positive T-wave alternans and Late potentials
Full Information
NCT ID
NCT00944775
First Posted
April 9, 2009
Last Updated
October 25, 2017
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT00944775
Brief Title
Exercise and Cardiac Measures in Dialysis Patients
Official Title
Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death
Keywords
Exercise, Dialysis, Non-invasive cardiac measures, Exercise trained patients, Controls
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise training
Arm Type
Experimental
Arm Description
10-month exercise training program
Arm Title
controls
Arm Type
No Intervention
Arm Description
usual care sedentary lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Group A, group B
Intervention Description
10-month exercise training program during hemodialysis sessions
Primary Outcome Measure Information:
Title
The composite risk score
Time Frame
at entry and after 10 months
Secondary Outcome Measure Information:
Title
aerobic capacity (VO2peak)
Time Frame
At entry and after 10 months
Title
Left ventricular ejection fraction (EF)- echocardiography
Time Frame
At entry and after 10 months
Title
standard deviation of normal R-R intervals- SDNN (holter monitoring)
Time Frame
At entry and after 10 months
Title
positive T-wave alternans and Late potentials
Time Frame
At entry and after 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelia J Kouidi, Associate Pr
Organizational Affiliation
Aristotle University of Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Sports Medicine
City
Thessaloniki
ZIP/Postal Code
546 35
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
35018639
Citation
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.
Results Reference
derived
PubMed Identifier
19646801
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise and Cardiac Measures in Dialysis Patients
We'll reach out to this number within 24 hrs