Rehabilitation and Outcome for Patients on LVAD Support

Not Applicable

• Conditions: Exercise Capacity; Quality of Life
• Interventions: Other: multi-module rehabilitation program

• Registration Number: NCT00781807
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Study Start: 2008-11
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25
• Primary Completion: 2013-10
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	multi-module rehabilitation program	The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Maximum exercise capacity	between hospital discharge after LVAD implant and explantation at least three month
Anxiety and depression scores	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

Trial Locations

Locations (2)

Hannover Medical School; 🇩🇪 Hannover, Germany

Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery; 🇩🇪 Hannover, Germany