Rehabilitation and Outcome for Patients on LVAD Support

Sponsor

Hannover Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT00781807

Collaborator

Deutsche Stiftung für Herzforschung (Other), German Federal Ministry of Education and Research (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Capacity Quality of Life	Other: multi-module rehabilitation program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support	Other: multi-module rehabilitation program The multi-module rehabilitation program includes: Nutrition management Home-based ergometer training program Psychosocial support Other Names: LVAD long-term support HRQoL ergometer training nutrition management

Arm

Intervention/Treatment

Experimental: 1

The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support

Other: multi-module rehabilitation program

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

Other Names:

LVAD

long-term support

HRQoL

ergometer training

nutrition management

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Hannover		Germany	30625
2	Hannover Medical School	Hannover		Germany	30625