Rehabilitation and Outcome for Patients on LVAD Support

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes

Conditions
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Exercise Capacity, Quality of Life

Intervention / Treatment
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* Other: multi-module rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support | Other: multi-module rehabilitation program<br>* The multi-module rehabilitation program includes: Nutrition management Home-based ergometer training program Psychosocial support<br>* Other names: nutrition management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart-Assist-Devices, Rehabilitation, Outcome Assessment (Health Care), Exercise Capacity, Ergometry, Social Support, Quality of Life, Nutrition Assessment, Nutrition Therapy, Neuropsychological Tests