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Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia

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ClinicalTrials.gov Identifier: NCT04075253
Recruitment Status : Enrolling by invitation
First Posted : August 30, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Defibrillators, Implantable Behavioral: VO2 peak testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VO2 peak test
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
Behavioral: VO2 peak testing
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.
Other Name: Cardiopulmonary Exercise Testing (CPET)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in number of inappropriate shocks

  2. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in stimulation threshold

  3. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in lead impedance

  4. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in atrial and ventricular refractory period

  5. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in restitution time of the sinus node

  6. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [ Time Frame: 24 hours ]
    Evaluated by changes in refractory period of the AV-node

  7. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075253


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Rune Wiseth, MD, Prof St. Olavs Hospital

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04075253     History of Changes
Other Study ID Numbers: 2018/1592-b
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary and secondary outcome measures will be made available after deidentification and publication
Time Frame: After publication
Access Criteria: Not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Exercise Training
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes