Rehabilitation and Outcome for Patients on LVAD Support

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00781807
• Other study ID #: DSfH-Project-No. F/05/08
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2008
• Last updated: August 24, 2009
• Start date: November 2008
• Est. completion date: April 2014

Study information

• Verified date: August 2009
• Source: Hannover Medical School
• Contact: Christiane Kugler
• Phone: 0049-511-532 6586
• Email: kugler.christiane[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Exercise Capacity
• Quality of Life

Intervention

Other:
• multi-module rehabilitation program
The multi-module rehabilitation program includes: Nutrition management Home-based ergometer training program Psychosocial support

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover
Germany	Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Hannover

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	Deutsche Stiftung für Herzforschung, German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anxiety and depression scores		between hospital discharge after LVAD implant and explantation at least three month	No
Secondary	Maximum exercise capacity		between hospital discharge after LVAD implant and explantation at least three month	No
Secondary	Body mass index		between hospital discharge after LVAD implant and explantation at least three month	No
Secondary	Neurologic events		between hospital discharge after LVAD implant and explantation at least three month	No
Secondary	Adverse events		between hospital discharge after LVAD implant and explantation at least three month	No