Skip to main content
OpenTrials
Completed

NCT Number: NCT04070300

Physical Activity and Ventricular Arrhythmias

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tachycardia, Ventricular Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Defibrillators, Implantable Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.