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Rehabilitation and Outcome for Patients on LVAD Support

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Deutsche Stiftung für Herzforschung (DSfH)
German Federal Ministry of Education and Research
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00781807
First received: October 28, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

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 Intervention
Exercise Capacity
Quality of Life
Other: multi-module rehabilitation program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety and depression scores [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
  • Maximum exercise capacity [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
  • Neurologic events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: between hospital discharge after LVAD implant and explantation at least three month ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781807

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

Locations
Germany
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         
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         
Sponsors and Collaborators
Hannover Medical School
Deutsche Stiftung für Herzforschung (DSfH)
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane Kugler Hannover Medical School
  More Information

No publications provided

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
Study First Received: October 28, 2008
Last Updated: August 24, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 20, 2014