Physical Activity and Ventricular Arrhythmias

April 25, 2023 updated by: St. Olavs Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from baseline and after ended intervention period (12 weeks)
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
Change from baseline and after intervention period (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and the last 4 weeks of intervention period (week 9-12)
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)
Baseline and the first 4 weeks after intervention period (week 13-16)
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)
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
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)
Baseline and the last 4 weeks of intervention period (week 9-12)
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)
Baseline and the first 4 weeks after intervention period (week 13-16)
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)
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
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)
Baseline and the last 4 weeks of intervention period (week 9-12)
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)
Baseline and the first 4 weeks after intervention period (week 13-16)
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)
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
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)
Baseline and the last 4 weeks of intervention period (week 9-12)
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)
Baseline and the first 4 weeks after intervention period (week 13-16)
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)
Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)
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)
Baseline and after ended intervention period (12 weeks)
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)
Baseline and after ended intervention period (12 weeks)
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
Baseline and after ended intervention period (12 weeks)
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
Baseline and after ended intervention period (12 weeks)
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
Baseline and after ended intervention period (12 weeks)
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
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)
Time Frame: Baseline and after ended intervention period (12 weeks)
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)
Time Frame: Baseline and after ended intervention period (12 weeks)
Measured by quantifying late potentials after depolarization of the ventricles
Baseline and after ended intervention period (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rune Wiseth, MD, Prof, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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