ClinicalTrials.gg
Status unknownNCT00781807Updated Aug 25, 2009

Rehabilitation and Outcome for Patients on LVAD Support

An interventional study of multi-module rehabilitation program in Exercise Capacity and Quality of Life, sponsored by Hannover Medical School. Status unknown at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exercise Capacity
  • Quality of Life

Keywords

  • Heart-Assist-Devices
  • Rehabilitation
  • Outcome Assessment (Health Care)
  • Exercise Capacity
  • Ergometry
  • Social Support
  • Quality of Life
  • Nutrition Assessment
  • Nutrition Therapy
  • Neuropsychological Tests
03

In context

Lead sponsor

Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe ventricular arrhythmia
  • Severe orthopaedic comorbidities
  • Illiteracy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    1

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

    Other: multi-module rehabilitation program

Interventions

  • Othermulti-module rehabilitation program

    The multi-module rehabilitation program includes: 1. Nutrition management 2. Home-based ergometer training program 3. Psychosocial support

    Also known as: LVAD, long-term support, HRQoL, ergometer training, nutrition management

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

2 of 2 sites recruiting
  • Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
    Hanover, 30625, Germany
    • Christiane Kugler · Contact · kugler.christiane@mh-hannover.de · 0049-511-532 6586
    • Christiane Kugler · Principal investigator
    • Doris Malehsa · Sub investigator
    • Uwe Tegtbur · Sub investigator
    • Martin Strüber · Sub investigator
    Recruiting
  • Hannover Medical School
    Hanover, 30625, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00781807
Collaborators
Deutsche Stiftung für Herzforschung, German Federal Ministry of Education and Research
First posted
Oct 29, 2008
Start date
Nov 2008
Primary completion
Oct 2013 (estimated)
Completion
Apr 2014 (estimated)
Last update
Aug 25, 2009

Study contacts

Christiane Kugler
Contact
kugler.christiane@mh-hannover.de
0049-511-532 6586
Christiane Kugler
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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