Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Locations
- 2
- Primary Endpoint
- Anxiety and Depression
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Anxiety and Depression
Secondary Outcomes
No secondary outcomes reported