Exercise Capacity, Quality of Life
Conditions
Keywords
Heart-Assist-Devices, Rehabilitation, Outcome Assessment (Health Care), Exercise Capacity, Ergometry, Social Support, Quality of Life, Nutrition Assessment, Nutrition Therapy, Neuropsychological Tests
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.
Interventions
OTHERmulti-module rehabilitation program
The multi-module rehabilitation program includes: 1. Nutrition management 2. Home-based ergometer training program 3. Psychosocial support
Sponsors
Deutsche Stiftung für Herzforschung
German Federal Ministry of Education and Research
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month | between hospital discharge after LVAD implant and explantation at least three month |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety and depression scores | between hospital discharge after LVAD implant and explantation at least three month |
| Maximum exercise capacity | 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 |
Countries
Germany
Contacts
Primary ContactChristiane Kugler
Outcome results
None listed