Clinical trial NCT00781807: Rehabilitation and Outcome for Patients on LVAD Support
Official title: Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Capacity
Quality of Life
Keywords: Heart-Assist-Devices
Rehabilitation
Outcome Assessment (Health Care)
Exercise Capacity
Ergometry
Social Support
Quality of Life
Nutrition Assessment
Nutrition Therapy
Neuropsychological Tests
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
name: German Federal Ministry of Education and Research
First posted: 2008-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
Secondary outcomes:
measure: Anxiety and depression scores
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
measure: Maximum exercise capacity
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
measure: Body mass index
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
measure: Neurologic events
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
measure: Adverse events
timeFrame: between hospital discharge after LVAD implant and explantation at least three month
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Christiane Kugler
role: PRINCIPAL_INVESTIGATOR
References: