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

NCT ID: NCT01038960

Last Updated: 2016-08-25

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise training

training

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

3 months supervised interval training

Not training

No organized training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

3 months supervised interval training

Intervention Type BEHAVIORAL

Other Intervention Names

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ICD, exercise training

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stavanger Health Research

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alf Inge Larsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Stavanger Health Research

Stavanger, , Norway

Site Status

Countries

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Norway

Other Identifiers

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068.08

Identifier Type: REGISTRY

Identifier Source: secondary_id

ETHIC-SUS-AIL-09

Identifier Type: -

Identifier Source: org_study_id

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