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Rehabilitation and Outcome for Patients on LVAD Support

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ClinicalTrials.gov Identifier: NCT00781807
Recruitment Status : Unknown
Verified August 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : October 29, 2008
Last Update Posted : August 25, 2009
Sponsor:
Collaborators:
Deutsche Stiftung für Herzforschung
German Federal Ministry of Education and Research
Information provided by:
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.

Condition or disease Intervention/treatment
Exercise Capacity Quality of Life Other: multi-module rehabilitation program

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  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : November 2008
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Anxiety and depression scores [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ]
  2. Maximum exercise capacity [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ]
  3. Body mass index [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ]
  4. Neurologic events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ]
  5. Adverse events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781807


Contacts
Contact: Christiane Kugler 0049-511-532 6586 kugler.christiane@mh-hannover.de

Locations
Germany
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery Recruiting
Hannover, Germany, 30625
Contact: Christiane Kugler    0049-511-532 6586    kugler.christiane@mh-hannover.de   
Principal Investigator: Christiane Kugler         
Sub-Investigator: Doris Malehsa         
Sub-Investigator: Uwe Tegtbur         
Sub-Investigator: Martin Strüber         
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Christiane Kugler, PhD    ++49.511.532 ext 6586    kugler.christiane@mh-hannover.de   
Principal Investigator: Christiane Kugler, PhD         
Sponsors and Collaborators
Hannover Medical School
Deutsche Stiftung für Herzforschung
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane Kugler Hannover Medical School

Responsible Party: Dr. rer.biol. hum. Christiane Kugler, Hannover Medical School, Clinic für Cardiac, Thoracic, Transplantation and Vascular Surgery, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
ClinicalTrials.gov Identifier: NCT00781807     History of Changes
Other Study ID Numbers: DSfH-Project-No. F/05/08
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Hannover Medical School:
Heart-Assist-Devices
Rehabilitation
Outcome Assessment (Health Care)
Exercise Capacity
Ergometry
Social Support
Quality of Life
Nutrition Assessment
Nutrition Therapy
Neuropsychological Tests