NCT01038960

Brief Summary

Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

4.7 years

First QC Date

December 22, 2009

Last Update Submit

August 24, 2016

Conditions

Ventricular Tachycardia

Keywords

ICD, training

Outcome Measures

Primary Outcomes (1)

  • Therapy delivered from ICD, Anxiety score, functional status

    3 months

Secondary Outcomes (1)

  • HRV, Endothelial function

    3 months

Study Arms (2)

Exercise training

EXPERIMENTAL

training

Behavioral: Exercise training

Not training

NO INTERVENTION

No organized training

Interventions

Exercise trainingBEHAVIORAL

3 months supervised interval training

Also known as: ICD, exercise training
Exercise training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger Health Research

Stavanger, Norway

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Exercise

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alf Inge Larsen, MD, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

April 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)