Physical Activity and Ventricular Arrhythmias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2022-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04075253

Tachycardia, Ventricular Defibrillators, Implantable

COMPLETED NA

Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety

NCT01038960

Ventricular Tachycardia

COMPLETED PHASE3

Exercise After an ICD

NCT00522340

Defibrillators, Implantable Heart Failure, Congestive

COMPLETED PHASE2

Exercise Training in Patients With Cardioverter-Defibrillators

NCT00754663

Arrhythmia

UNKNOWN NA

Aerobic Interval Training in Cardiac Rehabilitation

NCT00964067

Myocardial Infarction Coronary Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tachycardia, Ventricular Defibrillators, Implantable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interval training group

Aerobic interval training during 12 weeks 3 times a week.

Group Type EXPERIMENTAL

Interval exercise

Intervention Type BEHAVIORAL

Aerobic interval training during 12 weeks 3 times a week: 4 x 4 minutes intervals at an intensity of 90-95% of VO2 peak and active breaks of 3 minutes between intervals.

Control group

No lifestyle recommendations. Usual daily life.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interval exercise

Aerobic interval training during 12 weeks 3 times a week: 4 x 4 minutes intervals at an intensity of 90-95% of VO2 peak and active breaks of 3 minutes between intervals.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

interval training aerobic exercise training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No