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Rehabilitation and Outcome for Patients on LVAD Support

H

Hannover Medical School (MHH)

Status

Unknown

Conditions

Quality of Life
Exercise Capacity

Treatments

Other: multi-module rehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT00781807
DSfH-Project-No. F/05/08

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

1
Experimental group
Description:
The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support
Treatment:
Other: multi-module rehabilitation program

Trial contacts and locations

2

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Central trial contact

Christiane Kugler

Data sourced from clinicaltrials.gov

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