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Completed

NCT Number: NCT04075253

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VO2 peak testing

Behavioral

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Acute Effect of One Single Bout of High Intensity Exercise. A Substudy of the Study on Physical Activity and Ventricular Arrhythmias

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2019
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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