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

Phase 3

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Behavioral: Exercise training

• Registration Number: NCT01038960
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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

Detailed Description

ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD

Exclusion Criteria

• 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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training	Exercise training	training

Primary Outcome Measures

Name	Time	Method
Therapy delivered from ICD, Anxiety score, functional status	3 months

Secondary Outcome Measures

Name	Time	Method
HRV, Endothelial function	3 months

Trial Locations

Locations (1)

Stavanger Health Research; 🇳🇴 Stavanger, Norway