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

Not Applicable

Completed

• Conditions: Tachycardia, Ventricular; Defibrillators, Implantable
• Interventions: Behavioral: VO2 peak testing

• Registration Number: NCT04075253
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2019-09-02
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VO2 peak test	VO2 peak testing	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway