Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
研究概览
简要总结
A prospective, multi-module intervention based on nutrition management, psychosocial support, and a controlled home-based physical exercise training program for patients on LVAD- support will be provided to improve outcomes in terms of survival and patients health-related quality of life (HRQoL) for the long-term. Physical capacity, neurocognitive, psychological factors, and adverse events will be assessed as potential independent indicators for HRQoL.
详细描述
The multi-module intervention program for patients on LVAD support includes nutrition management, home-based ergometer training program, psychosocial support and neurocognitive screening. The nutrition management and physical reconditioning program will be supplemented by psychosocial support targeting the risk of increased stress, anxiety, and depression level. Moreover, standardized neurocognitive screening procedures will be administered to detect neurocognitive dysfunction (except stroke) and will be assessed for their potential to predict limitations in QoL. Adverse events like re-hospitalizations, thromboembolic and bleeding events will be monitored and assessed for their potential to negatively impact QoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •All eligible patients after LVAD implantation for long-term support with follow-up at our outpatient clinic
- •Written informed consent
- •Sufficient German language skills to read and answer a battery of questionnaires
- •18 years and older
排除标准
- •Severe ventricular arrhythmia
- •Severe orthopaedic comorbidities
- •Illiteracy
结局指标
主要结局
Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
时间窗: between hospital discharge after LVAD implant and explantation at least three month
次要结局
- Maximum exercise capacity(between hospital discharge after LVAD implant and explantation at least three month)
- Anxiety and depression scores(between hospital discharge after LVAD implant and explantation at least three month)
- Body mass index(between hospital discharge after LVAD implant and explantation at least three month)
- Neurologic events(between hospital discharge after LVAD implant and explantation at least three month)
- Adverse events(between hospital discharge after LVAD implant and explantation at least three month)