Rehabilitation and Outcome for Patients on LVAD Support

August 24, 2009 updated by: Hannover Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Recruiting
        • Hannover Medical School
        • Principal Investigator:
          • Christiane Kugler, PhD
      • Hannover, Germany, 30625
        • Recruiting
        • Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
        • Contact:
        • Sub-Investigator:
          • Doris Malehsa
        • Sub-Investigator:
          • Uwe Tegtbur
        • Sub-Investigator:
          • Martin Strüber

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:

  1. Nutrition management
  2. Home-based ergometer training program
  3. Psychosocial support
Other Names:
  • LVAD
  • long-term support
  • HRQoL
  • ergometer training
  • nutrition management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
Time Frame: 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

Outcome Measure
Time Frame
Anxiety and depression scores
Time Frame: between hospital discharge after LVAD implant and explantation at least three month
between hospital discharge after LVAD implant and explantation at least three month
Maximum exercise capacity
Time Frame: between hospital discharge after LVAD implant and explantation at least three month
between hospital discharge after LVAD implant and explantation at least three month
Body mass index
Time Frame: between hospital discharge after LVAD implant and explantation at least three month
between hospital discharge after LVAD implant and explantation at least three month
Neurologic events
Time Frame: between hospital discharge after LVAD implant and explantation at least three month
between hospital discharge after LVAD implant and explantation at least three month
Adverse events
Time Frame: between hospital discharge after LVAD implant and explantation at least three month
between hospital discharge after LVAD implant and explantation at least three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

German Federal Ministry of Education and Research
Deutsche Stiftung für Herzforschung

Investigators

  • Principal Investigator: Christiane Kugler, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (ESTIMATE)

October 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DSfH-Project-No. F/05/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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