Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hannover Medical School
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Severe ventricular arrhythmia
- •Severe orthopaedic comorbidities
- •Illiteracy
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)