Exercise and Cardiac Measures in Dialysis Patients

Sudden Cardiac Death Clinical Trial

Official title:

Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944775
• Other study ID #: RenalRehab
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: October 25, 2017
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2017
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

Behavioral:
• Exercise training
10-month exercise training program during hemodialysis sessions

Locations

Country	Name	City	State
Greece	Laboratory of Sports Medicine	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite risk score		at entry and after 10 months
Secondary	aerobic capacity (VO2peak)		At entry and after 10 months
Secondary	Left ventricular ejection fraction (EF)- echocardiography		At entry and after 10 months
Secondary	standard deviation of normal R-R intervals- SDNN (holter monitoring)		At entry and after 10 months
Secondary	positive T-wave alternans and Late potentials		At entry and after 10 months