Exercise CapacityNCT00781807
Rehabilitation and Outcome for Patients on LVAD Support
A study testing multi-module rehabilitation program in people with Exercise Capacity and Quality of Life, run by Hannover Medical School at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Capacity, Quality of Life
- What is being tested?
- multi-module rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2008to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe ventricular arrhythmia
- Severe orthopaedic comorbidities
- Illiteracy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, 30625
Christiane Kugler, 0049-511-532 6586, kugler.christiane@mh-hannover.de
Christiane Kugler
- Recruiting
Hannover Medical School
Hanover, 30625
Christiane Kugler, PhD, ++49.511.532 ext. 6586, kugler.christiane@mh-hannover.de
Christiane Kugler, PhD
About this study
Official title: Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
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.
- Conditions
- Exercise Capacity, Quality of Life
- Being tested
- multi-module rehabilitation program
- Keywords
- Heart-Assist-Devices, Rehabilitation, Outcome Assessment (Health Care), Exercise Capacity, Ergometry, Social Support, Quality of Life, Nutrition Assessment, Nutrition Therapy, Neuropsychological Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-module rehabilitation programOther
Also called LVAD, long-term support, HRQoL, ergometer training
The multi-module rehabilitation program includes:
- Nutrition management
- Home-based ergometer training program
- Psychosocial support
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support Receives: Other: multi-module rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Quality of Life between hospital discharge after LVAD implant and explantation at least three month
Measured: between hospital discharge after LVAD implant and explantation at least three month
Secondary outcomes (5)
Anxiety and depression scores
Measured: between hospital discharge after LVAD implant and explantation at least three month
Maximum exercise capacity
Measured: between hospital discharge after LVAD implant and explantation at least three month
Body mass index
Measured: between hospital discharge after LVAD implant and explantation at least three month
Neurologic events
Measured: between hospital discharge after LVAD implant and explantation at least three month
Adverse events
Measured: between hospital discharge after LVAD implant and explantation at least three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung, German Federal Ministry of Education and Research
- Investigators
- Christiane Kugler, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781807
- Sponsor's protocol ID
- DSfH-Project-No. F/05/08
- Status last verified
- Aug 2009
- First submitted
- 28 Oct 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-module Rehabilitation for Patients on LVAD Support - Impact on Long-term Outcomes
- ClinicalTrials.gov ID
- NCT00781807
- Acronym / sponsor ID
- DSfH-Project-No. F/05/08
- Conditions
- Exercise Capacity, Quality of Life
- Keywords
- Heart-Assist-Devices, Rehabilitation, Outcome Assessment (Health Care), Exercise Capacity, Ergometry, Social Support, Quality of Life, Nutrition Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung, German Federal Ministry of Education and Research
- Study start
- Nov 2008
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: multi-module rehabilitation programThe prospective intervention group with nutrition management, home-based bicycle ergometer training program and psychosocial support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Severe ventricular arrhythmia
- Severe orthopaedic comorbidities
- Illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-module rehabilitation programAlso: LVAD, long-term support, HRQoL, ergometer trainingThe multi-module rehabilitation program includes: 1. Nutrition management 2. Home-based ergometer training program 3. Psychosocial support | Other | 1 |
Primary outcome
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
5 secondary outcomes
Anxiety and depression scores
Time frame: between hospital discharge after LVAD implant and explantation at least three month
Maximum exercise capacity
Time frame: between hospital discharge after LVAD implant and explantation at least three month
Body mass index
Time frame: between hospital discharge after LVAD implant and explantation at least three month
Neurologic events
Time frame: between hospital discharge after LVAD implant and explantation at least three month
Adverse events
Time frame: between hospital discharge after LVAD implant and explantation at least three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
Related trials for Exercise Capacity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)
Respiratory Diseases
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Kugler principal investigator
Hannover Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-module rehabilitation program in people with Exercise Capacity and Quality of Life, run by Hannover Medical School at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane Kugler (0049-511-532 6586, kugler.christiane@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.