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

Tachycardia, Ventricular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075253
• Other study ID #: 2018/1592-b
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: September 2, 2022

Study information

• Verified date: April 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Defibrillators, Implantable
• Tachycardia
• Tachycardia, Ventricular

Intervention

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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tendency for ventricular arrhythmia	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	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in number of inappropriate shocks	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in stimulation threshold	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in lead impedance	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in atrial and ventricular refractory period	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in restitution time of the sinus node	24 hours
Secondary	Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)	Evaluated by changes in refractory period of the AV-node	24 hours
Secondary	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	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	Baseline and after 12 weeks