Rehabilitation and Outcome for Patients on LVAD Support
Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 25, 2009
August 1, 2009
4.9 years
October 28, 2008
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (1)
1
EXPERIMENTALThe prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support
Interventions
The multi-module rehabilitation program includes: 1. Nutrition management 2. Home-based ergometer training program 3. Psychosocial support
Eligibility Criteria
You may qualify if:
- 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
- years and older
You may not qualify if:
- Severe ventricular arrhythmia
- Severe orthopaedic comorbidities
- Illiteracy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Deutsche Stiftung für Herzforschungcollaborator
- German Federal Ministry of Education and Researchcollaborator
Study Sites (2)
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, 30625, Germany
Hannover Medical School
Hanover, 30625, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane Kugler
Hannover Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2013
Study Completion
April 1, 2014
Last Updated
August 25, 2009
Record last verified: 2009-08