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Clinical Trials/NCT04075253
NCT04075253
Completed
Not Applicable

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

St. Olavs Hospital1 site in 1 country55 target enrollmentSeptember 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tachycardia, Ventricular
Sponsor
St. Olavs Hospital
Enrollment
55
Locations
1
Primary Endpoint
Tendency for ventricular arrhythmia
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2019
End Date
September 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)(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(Baseline and after 12 weeks)

Study Sites (1)

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