Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346112
Status:
TERMINATED
Last Update Posted:
2010-11-09
First Post:
2006-06-28
Brief Title:
Rehabilitation Quality of Life and Exercise Tolerance in Patients With an ICD
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Rehabilitation Quality of Life and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients RELAX-ICD Trial
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RELAX-ICD TrialResearch Study Quality of LifeProtocol NoP-KARE-01 A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator ICD in adult patients whereby the effects of three different strategies are compared Study hypothesis the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention and will help to overcome anxiety and contribute to improved quality of life
Detailed Description:
University Hospital Inselspital BerneSwitzerland Site Nr 1 - Jean-Paul Schmid MD recruiting Virga JesseziekenhuisHasselt Belgium Site No 2 - Paul DendaleMD recruiting Medical University of Gdansk Poland Site No 3 - Dominika ZielinskaPhD recruiting Cliniques Universitaires Saint Luc Brussel Belgium Site No 4 - Christian BrohetMD Prof recruiting State Hospital for Cardiology Balantonfüred Hungary Site No 5 - Gabor Veress MD Prof recruiting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None