Tachycardia, VentricularNCT04070300
Physical Activity and Ventricular Arrhythmias
A study testing Interval exercise in people with Tachycardia, Ventricular and Defibrillators, Implantable, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular, Defibrillators, Implantable
- What is being tested?
- Interval exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNorway
- Study dates
- 2 Sep 2019to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Interval exercise
- Keywords
- Exercise Training
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval exerciseBehavioural
Also called interval training, aerobic exercise training
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.
| Study group | Role | What they receive |
|---|---|---|
| Interval training group | Experimental | Aerobic interval training during 12 weeks 3 times a week. Receives: Behavioral: Interval exercise |
| Control group | No intervention | No lifestyle recommendations. Usual daily life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical fitness/aerobic capacity
Expressed in and measured with maximal oxygen uptake (VO2 peak)
Measured: 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
Measured: Change from baseline and after intervention period (12 weeks)
Secondary outcomes (20)
Change in burden of ventricular arrhythmias from baseline to week 9-12
Evaluated by number of ICD discharges (registered on ICD)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and after ended intervention period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Sep 2019
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Rune Wiseth, MD, Prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070300
- Sponsor's protocol ID
- 2018/1592
- Status last verified
- Apr 2023
- First submitted
- 21 Aug 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT04070300
- Acronym / sponsor ID
- 2018/1592
- Keywords
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval training group | Experimental | Behavioral: Interval exerciseAerobic interval training during 12 weeks 3 times a week. |
| Control group | No intervention | –No lifestyle recommendations. Usual daily life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval exerciseAlso: interval training, aerobic exercise trainingAerobic 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. | Behavioural | Interval training group |
Primary outcome
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 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
20 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Cardiac function
Time frame: Baseline and after ended intervention period (12 weeks)
Change in degree of physical activity
Time frame: Baseline and after ended intervention period (12 weeks)
Changes in adiposity
Time frame: Baseline and after ended intervention period (12 weeks)
Changes in cholesterol value
Time frame: Baseline and after ended intervention period (12 weeks)
Changes in triglycerides value
Time frame: Baseline and after ended intervention period (12 weeks)
Changes in heart rate variability
Time frame: 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)
Changes in signal-averaged ECG (SA-ECG)
Time frame: Baseline and after ended intervention period (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
Related trials for Tachycardia, Ventricular
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Wiseth, MD, Prof study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval exercise in people with Tachycardia, Ventricular and Defibrillators, Implantable, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical fitness/aerobic capacity (time frame: Change from baseline and after ended intervention period (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.