Clinical trial NCT04070300: Physical Activity and Ventricular Arrhythmias
Official title: Physical Activity and Ventricular Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Defibrillators, Implantable
Keywords: Exercise Training
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-08-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in physical fitness/aerobic capacity
timeFrame: Change from baseline and after ended intervention period (12 weeks)
measure: Change in assessment of quality of life
timeFrame: Change from baseline and after intervention period (12 weeks)
Secondary outcomes:
measure: Change in burden of ventricular arrhythmias from baseline to week 9-12
timeFrame: Baseline and the last 4 weeks of intervention period (week 9-12)
measure: Change in burden of ventricular arrhythmias from baseline to week 13-16
timeFrame: Baseline and the first 4 weeks after intervention period (week 13-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-16
timeFrame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-12
timeFrame: Baseline and the last 4 weeks of intervention period (week 9-12)
measure: Change in burden of ventricular arrhythmias from baseline to week 13-16
timeFrame: Baseline and the first 4 weeks after intervention period (week 13-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-16
timeFrame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-12
timeFrame: Baseline and the last 4 weeks of intervention period (week 9-12)
measure: Change in burden of ventricular arrhythmias from baseline to week 13-16
timeFrame: Baseline and the first 4 weeks after intervention period (week 13-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-16
timeFrame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-12
timeFrame: Baseline and the last 4 weeks of intervention period (week 9-12)
measure: Change in burden of ventricular arrhythmias from baseline to week 13-16
timeFrame: Baseline and the first 4 weeks after intervention period (week 13-16)
measure: Change in burden of ventricular arrhythmias from baseline to week 9-16
timeFrame: Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
measure: Cardiac function
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Change in degree of physical activity
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in adiposity
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in cholesterol value
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in triglycerides value
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in heart rate variability
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in number of premature ventricular contractions during a single bout of high intensity exercise (VO2 peak test)
timeFrame: Baseline and after ended intervention period (12 weeks)
measure: Changes in signal-averaged ECG (SA-ECG)
timeFrame: Baseline and after ended intervention period (12 weeks)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Rune Wiseth, MD, Prof
role: STUDY_DIRECTOR
References: