Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 2
- 主要终点
- Anxiety and Depression
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ICD implant within past 12 weeks
- •Agrees to sign patient/partner informed consent
排除标准
- •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
结局指标
主要结局
Anxiety and Depression
次要结局
未报告次要终点