NCT00944775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

April 9, 2009

Last Update Submit

October 25, 2017

Conditions

Sudden Cardiac Death

Keywords

ExerciseDialysisNon-invasive cardiac measuresExercise trained patientsControls

Outcome Measures

Primary Outcomes (1)

  • The composite risk score

    at entry and after 10 months

Secondary Outcomes (4)

  • aerobic capacity (VO2peak)

    At entry and after 10 months

  • Left ventricular ejection fraction (EF)- echocardiography

    At entry and after 10 months

  • standard deviation of normal R-R intervals- SDNN (holter monitoring)

    At entry and after 10 months

  • positive T-wave alternans and Late potentials

    At entry and after 10 months

Study Arms (2)

exercise training

EXPERIMENTAL

10-month exercise training program

Behavioral: Exercise training

controls

NO INTERVENTION

usual care sedentary lifestyle

Interventions

Exercise trainingBEHAVIORAL

10-month exercise training program during hemodialysis sessions

Also known as: Group A, group B
exercise training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • on HD for at least 6 months
  • in sinus rhythm
  • able to reach a sufficient workload during ergometry

You may not qualify if:

  • with bundle branch block
  • unstable hypertension
  • diabetes mellitus
  • severe congestive heart failure
  • recent myocardial infarction
  • unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Sports Medicine

Thessaloniki, 546 35, Greece

Location

Related Publications (2)

  • 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.

    PMID: 35018639DERIVED

  • 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.

    PMID: 19646801DERIVED

MeSH Terms

Conditions

Death, Sudden, CardiacMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Evangelia J Kouidi, Associate Pr

    Aristotle University of Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Sports Medicine

Study Record Dates

First Submitted

April 9, 2009

First Posted

July 23, 2009

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

GR(1)