Physical Activity and Ventricular Arrhythmias

St. Olavs Hospital

Status

Completed

Conditions

Defibrillators, Implantable

Tachycardia, Ventricular

Treatments

Behavioral: Interval exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04070300

2018/1592

Details and patient eligibility

About

The purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (ICD) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

Full description

In this study, participants will be randomly assigned to either take part in the exercise program or serve as control and live as usual. At baseline study visit, study researchers will review medical records to collect various information, including the reason for needing an ICD, the type and settings of the ICD, medication use and medical history etc. All participants will undergo blood collection, complete a questionnaire to assess quality of life and undergo examination with echocardiography and ECG. The ICD will be programmed accordingly to international guidelines regarding ICD-therapy and optimal monitoring, before each participant complete an exercise treadmill test to determine VO2 peak. They will wear a Holter monitor to record heart activity 48 hours before the test and 24 hours after the test. All participants will then be observed for 2 months before being randomly assigned to either intervention or control. During this observation period, they will wear a fitness activity tracker wristband to evaluate degree of physical activity and a Holter monitor to register number of premature ventricular contractions. Participants taking part in the interval training group will perform aerobic interval training 4 x 4 minutes intervals, 3 times a week for 12 weeks (week 1-12), whereas participants taking part in the control group will carry on with usual daily life with no lifestyle recommendations. All participants will then undergo a new period of observation (week 13-20) and repeat the tests and examinations performed at baseline and during the observation period prior to intervention/control.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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