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.

Study Overview

• Status: Completed
• Conditions: Tachycardia, Ventricular; Defibrillators, Implantable
• Intervention / Treatment: Behavioral: Interval exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: aerobic exercise training; interval training
No Intervention: Control group; No lifestyle recommendations. Usual daily life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical fitness/aerobic capacity	Expressed in and measured with maximal oxygen uptake (VO2 peak)	Change from baseline and after ended intervention period (12 weeks)
Change in assessment of quality of life	Patient-reported survey of patient health SF-36	Change from baseline and after intervention period (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in burden of ventricular arrhythmias from baseline to week 9-12	Evaluated by number of ICD discharges (registered on ICD)	Baseline and the last 4 weeks of intervention period (week 9-12)
Change in burden of ventricular arrhythmias from baseline to week 13-16	Evaluated by number of ICD discharges (registered on ICD)	Baseline and the first 4 weeks after intervention period (week 13-16)
Change in burden of ventricular arrhythmias from baseline to week 9-16	Evaluated by number of ICD discharges (registered on ICD)	Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
Change in burden of ventricular arrhythmias from baseline to week 9-12	Evaluated by number of episodes with antitachycardia pacing (registered on ICD)	Baseline and the last 4 weeks of intervention period (week 9-12)
Change in burden of ventricular arrhythmias from baseline to week 13-16	Evaluated by number of episodes with antitachycardia pacing (registered on ICD)	Baseline and the first 4 weeks after intervention period (week 13-16)
Change in burden of ventricular arrhythmias from baseline to week 9-16	Evaluated by number of episodes with antitachycardia pacing (registered on ICD)	Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
Change in burden of ventricular arrhythmias from baseline to week 9-12	Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)	Baseline and the last 4 weeks of intervention period (week 9-12)
Change in burden of ventricular arrhythmias from baseline to week 13-16	Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)	Baseline and the first 4 weeks after intervention period (week 13-16)
Change in burden of ventricular arrhythmias from baseline to week 9-16	Evaluated by number of episodes with monitored ventricular tachycardias without ICD-therapy (registered on ICD)	Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
Change in burden of ventricular arrhythmias from baseline to week 9-12	Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)	Baseline and the last 4 weeks of intervention period (week 9-12)
Change in burden of ventricular arrhythmias from baseline to week 13-16	Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)	Baseline and the first 4 weeks after intervention period (week 13-16)
Change in burden of ventricular arrhythmias from baseline to week 9-16	Evaluated by number of premature ventricular contractions (registered on a 72 hours Holter monitoring)	Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
Cardiac function	Evaluated by changes in left ventricular dimensions and systolic/diastolic function assessed by echocardiography and blood values (NT-proBNP and troponin T)	Baseline and after ended intervention period (12 weeks)
Change in degree of physical activity	Assessed by number of steps daily registered with fitness activity tracker wristband (worn for 1 week)	Baseline and after ended intervention period (12 weeks)
Changes in adiposity	Evaluated by changes in waist circumference (cm) and BMI (kg/m^2) as measures of adiposity	Baseline and after ended intervention period (12 weeks)
Changes in cholesterol value	Evaluated by changes in total cholesterol, HDL-cholesterol, LDL-cholesterol (all in mmol/L) as a measure of cardiac risk	Baseline and after ended intervention period (12 weeks)
Changes in triglycerides value	Evaluated by changes in triglycerides ( in mmol/L) as a measure of cardiac risk	Baseline and after ended intervention period (12 weeks)
Changes in heart rate variability	Evaluated by measuring changes in SDNN, SDANN 5, ASDNN 5 and RMSSD registered on a 72 hours Holter monitoring	Baseline and after ended intervention period (12 weeks)
Changes in number of premature ventricular contractions during a single bout of high intensity exercise (VO2 peak test)	Measured by changes in the number of premature ventricular contractions during VO2 peak testing	Baseline and after ended intervention period (12 weeks)
Changes in signal-averaged ECG (SA-ECG)	Measured by quantifying late potentials after depolarization of the ventricles	Baseline and after ended intervention period (12 weeks)

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Rune Wiseth, MD, Prof, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Exercise Training
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 2018/1592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No