Rehabilitation and Outcome for Patients on LVAD Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Exercise Capacity Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

multi-module rehabilitation program

Intervention Type OTHER

The multi-module rehabilitation program includes:

1. Nutrition management
2. Home-based ergometer training program
3. Psychosocial support

Interventions

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multi-module rehabilitation program

The multi-module rehabilitation program includes:

1. Nutrition management
2. Home-based ergometer training program
3. Psychosocial support

Intervention Type OTHER

Other Intervention Names

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LVAD long-term support HRQoL ergometer training nutrition management

Eligibility Criteria

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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