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| Name | Class |
|---|---|
| Deutsche Stiftung fĂ¼r Herzforschung | OTHER |
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-module rehabilitation program | Other | The multi-module rehabilitation program includes:
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane Kugler | Contact | 0049-511-532 6586 | kugler.christiane@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Christiane Kugler | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery | Recruiting | Hanover | 30625 | Germany |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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|
| 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 |
| Hannover Medical School | Recruiting | Hanover | 30625 | Germany |
|
| D004778 |
| Environment and Public Health |
| D013812 | Therapeutics |