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.
Primary Outcome Measures:
- Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anxiety and depression scores [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
- Maximum exercise capacity [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
- Body mass index [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
- Neurologic events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
80 |
| Study Start Date: |
November 2008 |
| Estimated Study Completion Date: |
April 2014 |
| Estimated Primary Completion Date: |
October 2013 (Final data collection date for primary outcome measure) |
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1: Experimental
The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support
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Other: multi-module rehabilitation program
The multi-module rehabilitation program includes:
- Nutrition management
- Home-based ergometer training program
- Psychosocial support
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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.
Purpose
