Physical Activity and Ventricular Arrhythmias

NCT04070300 | Completed

• 1 other identifier: 2018/1592
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tachycardia, Ventricular; Defibrillators, Implantable

Keywords

Exercise Training

Outcome Measures

Primary Outcomes (2)

• Change in physical fitness/aerobic capacity

  Expressed in and measured with maximal oxygen uptake (VO2 peak)

  Change from baseline and after ended intervention period (12 weeks)

• Change in assessment of quality of life

  Patient-reported survey of patient health SF-36

  Change from baseline and after intervention period (12 weeks)

Secondary Outcomes (20)

• Change in burden of ventricular arrhythmias from baseline to week 9-12

  Baseline and the last 4 weeks of intervention period (week 9-12)

• Change in burden of ventricular arrhythmias from baseline to week 13-16

  Baseline and the first 4 weeks after intervention period (week 13-16)

• Change in burden of ventricular arrhythmias from baseline to week 9-16

  Baseline and the last 4 weeks of intervention period plus 4 first weeks after intervention period (week 9-16)

• Change in burden of ventricular arrhythmias from baseline to week 9-12

  Baseline and the last 4 weeks of intervention period (week 9-12)

• Change in burden of ventricular arrhythmias from baseline to week 13-16

  Baseline and the first 4 weeks after intervention period (week 13-16)

Study Arms (2)

Interval training group

EXPERIMENTAL

Aerobic interval training during 12 weeks 3 times a week.

Behavioral: Interval exercise

Control group

NO INTERVENTION

No lifestyle recommendations. Usual daily life.

Interventions

Interval exercise 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.

Also known as: interval training, aerobic exercise training

Interval training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation
• ICD implanted at St Olavs hospital, Trondheim

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rune Wiseth, MD, Prof

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: September 2, 2019
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Not yet decided

Locations

NO (1)