Tachycardia, VentricularNCT04075253
Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia
A study testing VO2 peak testing in people with Tachycardia, Ventricular and Defibrillators, Implantable, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia. 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?
- VO2 peak testing
- 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
Official title: Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
Read the detailed description
This study is a substudy of a planned study involving participants with an implantable cardioverter defibrillator (ICD), who will be randomly assigned to either take part in a exercise program for 12 weeks or serve as control and live as usual (Clinical Trials Unique Protocol ID: 2018/1592). In that study all participants will complete an exercise treadmill test to determine maximum oxygen uptake (VO2 peak).
In this study we wish to examine the acute effect of one single bout of high intensity exercise (i.e the VO2 peak test) on the tendency for ventricular arrhythmia. The study will evaluate changes in ICD-parameters and the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test.
The study will also examine if the acute effect after VO2 peak testing alters after completing 12 weeks of aerobic interval training or control respectively.
- Being tested
- VO2 peak testing
- 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.
VO2 peak testingBehavioural
Also called Cardiopulmonary Exercise Testing (CPET)
Exercise on treadmill starts with ~4km/h at 0% inclination before inclination is increased to 4% and speed kept unchanged. Inclination will then be increased with two percent approximately after each minute until exhaustion.
| Study group | Role | What they receive |
|---|---|---|
| VO2 peak test | Experimental | All participants enrolled in the planned study on physical activity and ventricular arrhythmias and on baseline will complete an exercise treadmill test to determine VO2 peak Receives: Behavioral: VO2 peak testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendency for ventricular arrhythmia
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
Measured: 24 hours
Secondary outcomes (7)
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in number of inappropriate shocks
Measured: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in stimulation threshold
Measured: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in lead impedance
Measured: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in atrial and ventricular refractory period
Measured: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in restitution time of the sinus node
Measured: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in refractory period of the AV-node
Measured: 24 hours
Changes in acute effect of one single bout of high intensity exercise on tendency for ventricular arrhythmia after either 3 months of interval exercise or control
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 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
- Not applicable
- Intervention model
- Single group
- 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
- NCT04075253
- Sponsor's protocol ID
- 2018/1592-b
- Status last verified
- Apr 2023
- First submitted
- 28 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
- Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT04075253
- Acronym / sponsor ID
- 2018/1592-b
- 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
- 30 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.
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.
Detailed description
This study is a substudy of a planned study involving participants with an implantable cardioverter defibrillator (ICD), who will be randomly assigned to either take part in a exercise program for 12 weeks or serve as control and live as usual (Clinical Trials Unique Protocol ID: 2018/1592). In that study all participants will complete an exercise treadmill test to determine maximum oxygen uptake (VO2 peak).
In this study we wish to examine the acute effect of one single bout of high intensity exercise (i.e the VO2 peak test) on the tendency for ventricular arrhythmia. The study will evaluate changes in ICD-parameters and the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test.
The study will also examine if the acute effect after VO2 peak testing alters after completing 12 weeks of aerobic interval training or control respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VO2 peak test | Experimental | Behavioral: VO2 peak testingAll participants enrolled in the planned study on physical activity and ventricular arrhythmias and on baseline will complete an exercise treadmill test to determine VO2 peak |
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 |
|---|---|---|
| VO2 peak testingAlso: Cardiopulmonary Exercise Testing (CPET)Exercise on treadmill starts with ~4km/h at 0% inclination before inclination is increased to 4% and speed kept unchanged. Inclination will then be increased with two percent approximately after each minute until exhaustion. | Behavioural | VO2 peak test |
Primary outcome
Tendency for ventricular arrhythmia
Time frame: 24 hours
Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring
7 secondary outcomes
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Time frame: 24 hours
Changes in acute effect of one single bout of high intensity exercise on tendency for ventricular arrhythmia after either 3 months of interval exercise or control
Time frame: Baseline and after 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
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Genetic Markers of Cardiovascular Disease in Epilepsy
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Recruiting
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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 VO2 peak testing 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?
Tendency for ventricular arrhythmia (time frame: 24 hours). 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.