Rehabilitation, Quality of Life, and Exercise Tolerance i... | NCT00346112

Studies
Rehabilitation, Quality of Life, and Exercise Tolerance in Patients With an ICD

NCT00346112

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Terminated

Last Update Posted

Nov 9, 2010Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Heart Patients After ICD Implantation

Interventions

psycho-educational

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient recruitment

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Dec 2009

First Submitted Date

Jun 28, 2006

First Submission Date that Met QC Criteria

Jun 28, 2006

First Posted Date

Jun 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Description Module

Brief Summary

RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-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 Berne,Switzerland: Site Nr. 1 - Jean-Paul Schmid, MD, ... recruiting / Virga Jesseziekenhuis,Hasselt, Belgium: Site No. 2 - Paul Dendale,MD,.... recruiting / Medical University of Gdansk, Poland, Site No. 3 - Dominika Zielinska,PhD,.... recruiting / Cliniques Universitaires Saint Luc, Brussel, Belgium: Site No. 4 - Christian Brohet,MD Prof.... recruiting / State Hospital for Cardiology, Balantonfüred, Hungary: Site No. 5 - Gabor Veress, MD Prof, ...recruiting

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
psycho-educational	Procedure

Measure	Description	Time Frame
Anxiety and Depression

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First ICD implant within past 12 weeks
Agrees to sign patient/partner informed consent

Exclusion Criteria:

Angina pectoris CCS III & IV
NYHA functional class IV
Inability to follow rehabilitation programme
Exercise limitations due to clinical condition
Symptomatic exercise-induced tachyarrhythmias
Any major non-cardiac condition that would adversely affect survival during study duration
Unable to comply to study procedures
Participates in a concurrent study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Paul Schmid	Switzerland - University Hospital (Inselspital) Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital (Inselspital) Berne		Bern		3010	Switzerland