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

H

Helse Stavanger HF

Status and phase

Completed
Phase 3

Conditions

Ventricular Tachycardia

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT01038960
ETHIC-SUS-AIL-09
068.08 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Exercise training
Experimental group
Description:
training
Treatment:
Behavioral: Exercise training
Not training
No Intervention group
Description:
No organized training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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