The Effect of Rehabilitation for Patients Living With an ICD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Physical capability
研究概览
简要总结
The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (ICD).
Hypothesis: The outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.
详细描述
Implantable cardioverter defibrillators (ICD) are used in the treatment of life-threatening heart arrhythmia and the prevention of sudden cardiac death (SCD). The ICD terminates arrhythmia by delivering therapy in the form of electrical impulses to the heart. Patients have described the high energy shock administered by the devise as feeling like a painful kick in the chest.
Patients, who receive an ICD are very much protected against SCD and it is assumed that they are less worried and effected by their heart disease than others. That is not correct though. Studies have shown, that living with an ICD can lead to anxiety, fear of shock and avoidance of situations, places and objects that are associated to shock. It often leads to social isolation, avoidance of physical activity and mood-disturbances.
The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with ICD.
Hypothesis: see above
Intervention: The outpatient nursing programme has a duration of 1 year and is directed towards parameters that ICD reportedly affect. The focus is prevention of the known risks and problems. The content is partly information and education in managing an ICD, partly emotional reactions and further discussion of handling life with ICD. 3-month into the program physical training lead by a physical therapist is started. It is optimal whether to carry out the twice-weekly physical training program at home or at the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •In-patients at Copenhagen University Hospital who just received an ICD for the first time.
排除标准
- •Patients who:
- •do not understand the instructions,
- •are under 18 years old,
- •are diagnosed with a mental disease,
- •suffer from a competing disease,
- •can not participate in physical training.
结局指标
主要结局
Physical capability
时间窗: 3-6-12 month
Quality of life
时间窗: 3 -6-12 month
次要结局
未报告次要终点
研究者
Selina Kikkenborg Berg
Ph.D.
Rigshospitalet, Denmark
