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Physical Activity and Ventricular Arrhythmias

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ClinicalTrials.gov Identifier: NCT04070300
Recruitment Status : Enrolling by invitation
First Posted : August 27, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
The purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (ICD) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Defibrillators, Implantable Behavioral: Interval exercise Not Applicable

Detailed Description:
In this study, participants will be randomly assigned to either take part in the exercise program or serve as control and live as usual. At baseline study visit, study researchers will review medical records to collect various information, including the reason for needing an ICD, the type and settings of the ICD, medication use and medical history etc. All participants will undergo blood collection, complete a questionnaire to assess quality of life and undergo examination with echocardiography and ECG. The ICD will be programmed accordingly to international guidelines regarding ICD-therapy and optimal monitoring, before each participant complete an exercise treadmill test to determine VO2 peak. They will wear a Holter monitor to record heart activity 48 hours before the test and 24 hours after the test. All participants will then be observed for 2 months before being randomly assigned to either intervention or control. During this observation period, they will wear a fitness activity tracker wristband to evaluate degree of physical activity and a Holter monitor to register number of premature ventricular contractions. Participants taking part in the interval training group will perform aerobic interval training 4 x 4 minutes intervals, 3 times a week for 12 weeks (week 1-12), whereas participants taking part in the control group will carry on with usual daily life with no lifestyle recommendations. All participants will then undergo a new period of observation (week 13-20) and repeat the tests and examinations performed at baseline and during the observation period prior to intervention/control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity and Ventricular Arrhythmias
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022


Arm Intervention/treatment
Experimental: Interval training group
Aerobic interval training during 12 weeks 3 times a week.
Behavioral: Interval exercise
Aerobic interval training during 12 weeks 3 times a week: 4 x 4 minutes intervals at an intensity of 90-95% of VO2 peak and active breaks of 3 minutes between intervals.
Other Names:
  • interval training
  • aerobic exercise training

No Intervention: Control group
No lifestyle recommendations. Usual daily life.



Primary Outcome Measures :
  1. Change in physical fitness/aerobic capacity [ Time Frame: Change from baseline and after ended intervention period (12 weeks) ]
    Expressed in and measured with maximal oxygen uptake (VO2 peak)

  2. Change in assessment of quality of life [ Time Frame: Change from baseline and after intervention period (12 weeks) ]
    Patient-reported survey of patient health SF-36


Secondary Outcome Measures :
  1. Change in burden of ventricular arrhythmias from baseline to week 9-12 [ Time Frame: Baseline and the last 4 weeks of intervention period (week 9-12) ]
    Evaluated by number of ICD discharges (registered on ICD)

  2. Change in burden of ventricular arrhythmias from baseline to week 13-16 [ Time Frame: Baseline and the first 4 weeks after intervention period (week 13-16) ]
    Evaluated by number of ICD discharges (registered on ICD)

  3. Change in burden of ventricular arrhythmias from baseline to week 9-16 [ Time Frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16) ]
    Evaluated by number of ICD discharges (registered on ICD)

  4. Change in burden of ventricular arrhythmias from baseline to week 9-12 [ Time Frame: Baseline and the last 4 weeks of intervention period (week 9-12) ]
    Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

  5. Change in burden of ventricular arrhythmias from baseline to week 13-16 [ Time Frame: Baseline and the first 4 weeks after intervention period (week 13-16) ]
    Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

  6. Change in burden of ventricular arrhythmias from baseline to week 9-16 [ Time Frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16) ]
    Evaluated by number of episodes with antitachycardia pacing (registered on ICD)

  7. Change in burden of ventricular arrhythmias from baseline to week 9-12 [ Time Frame: Baseline and the last 4 weeks of intervention period (week 9-12) ]
    Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)

  8. Change in burden of ventricular arrhythmias from baseline to week 13-16 [ Time Frame: Baseline and the first 4 weeks after intervention period (week 13-16) ]
    Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)

  9. Change in burden of ventricular arrhythmias from baseline to week 9-16 [ Time Frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16) ]
    Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)

  10. Change in burden of ventricular arrhythmias from baseline to week 9-12 [ Time Frame: Baseline and the last 4 weeks of intervention period (week 9-12) ]
    Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)

  11. Change in burden of ventricular arrhythmias from baseline to week 13-16 [ Time Frame: Baseline and the first 4 weeks after intervention period (week 13-16) ]
    Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)

  12. Change in burden of ventricular arrhythmias from baseline to week 9-16 [ Time Frame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16) ]
    Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)

  13. Cardiac function [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Evaluated by changes in left ventricular dimensions and systolic/diastolic function assessed by echocardiography and blood values (NT-proBNP and troponin T)

  14. Change in degree of physical activity [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Assessed by number of steps daily registered with fitness activity tracker wristband (worn for 1 week)

  15. Changes in adiposity [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Evaluated by changes in waist circumference (cm) and BMI (kg/m^2) as measures of adiposity

  16. Changes in cholesterol value [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Evaluated by changes in total cholesterol, HDL-cholesterol, LDL-cholesterol (all in mmol/L) as a measure of cardiac risk

  17. Changes in triglycerides value [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Evaluated by changes in triglycerides ( in mmol/L) as a measure of cardiac risk

  18. Changes in heart rate variability [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Evaluated by measuring changes in SDNN, SDANN 5, ASDNN 5 and RMSSD registered on a 72 hours Holter monitoring

  19. Changes in number of premature ventricular contractions during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Measured by changes in the number of premature ventricular contractions during VO2 peak testing

  20. Changes in signal-averaged ECG (SA-ECG) [ Time Frame: Baseline and after ended intervention period (12 weeks) ]
    Measured by quantifying late potentials after depolarization of the ventricles



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation
  • ICD implanted at St Olavs hospital, Trondheim

In case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation.

Exclusion Criteria:

  • inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons
  • signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk
  • comorbidity where endurance training at more than moderate intensity is discouraged
  • severe cardiac valve disease
  • planned surgery within the next 3 months
  • inability to give informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT04070300


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Rune Wiseth, MD, Prof St. Olavs Hospital

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04070300     History of Changes
Other Study ID Numbers: 2018/1592
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
Time Frame: After publication
Access Criteria: Not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Exercise Training
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes