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

Sponsor
St. Olavs Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04075253
Collaborator
Norwegian University of Science and Technology (Other)
55
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VO2 peak testing
 N/A

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

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
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 :
Sep 2, 2019
Actual Primary Completion Date :
Jan 18, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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 Names:
  • Cardiopulmonary Exercise Testing (CPET)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tendency for ventricular arrhythmia [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) [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) [24 hours]

      Evaluated by changes in stimulation threshold

    3. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [24 hours]

      Evaluated by changes in lead impedance

    4. Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test) [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) [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) [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Olavs Hospital Trondheim Norway

    Sponsors and Collaborators

    • St. Olavs Hospital
    • Norwegian University of Science and Technology

    Investigators

    • Study Director: Rune Wiseth, MD, Prof, St. Olavs Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St. Olavs Hospital
    ClinicalTrials.gov Identifier:
    NCT04075253
    Other Study ID Numbers:
    • 2018/1592-b
    First Posted:
    Aug 30, 2019
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Tachycardia
    Tachycardia, Ventricular

    Study Results

    No Results Posted as of Jun 15, 2022