Back to resultsAcute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia
Primary Purpose
Tachycardia, Ventricular, Defibrillators, Implantable
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
VO2 peak testing
Sponsored by
About this trial
This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring Exercise Training
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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VO2 peak test
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in number of inappropriate shocks
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in stimulation threshold
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in lead impedance
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Evaluated by changes in atrial and ventricular refractory period
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
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
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
Full Information
NCT ID
NCT04075253
First Posted
August 28, 2019
Last Updated
April 25, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04075253
Brief Title
Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia
Official Title
Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular, Defibrillators, Implantable
Keywords
Exercise Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VO2 peak test
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
VO2 peak testing
Other Intervention Name(s)
Cardiopulmonary Exercise Testing (CPET)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tendency for ventricular arrhythmia
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in number of inappropriate shocks
Time Frame
24 hours
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in stimulation threshold
Time Frame
24 hours
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in lead impedance
Time Frame
24 hours
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in atrial and ventricular refractory period
Time Frame
24 hours
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in restitution time of the sinus node
Time Frame
24 hours
Title
Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)
Description
Evaluated by changes in refractory period of the AV-node
Time Frame
24 hours
Title
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
Description
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
Time Frame
Baseline and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, MD, Prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia
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