Rehabilitation and Outcome for Patients on LVAD Support
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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:
Other Names:
|
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 |
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| Contact: Christiane Kugler | 0049-511-532 6586 | kugler.christiane@mh-hannover.de |
| 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 | |
| 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 May 22, 2013