- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984162
Influence of Individualized Training on Cardiopulmonary Exercise Capacity in LVAD Patients
Influence of Individualized, Spiroergometry Guided, Structural Training on Cardiopulmonary Exercise Capacity in Patients With a Left Ventricular Assist Device
Study Overview
Status
Conditions
Detailed Description
b.) Current European guidelines for prevention of cardiovascular disease recommend regular training for patients suffering from any cardiovascular disease. Studies have shown that regular training results in an improvement of cardiopulmonary exercise capacity. Objective parameters such as peak VO2 and VE/ VCO2 slope can be positively influenced by training in patients with heart failure. Only few studies suggest a beneficial impact on exercise capacity in patients with an implanted ventricular assist device (LVAD), but literature on this topic is scarce. So far there are no recommendations for a standardized exercise protocol for LVAD.
The aim of this prospective monocentric study is to examine the influence of an individualized, spiroergometry- guided training protocol on cardiopulmonary fitness in patients with an implanted LVAD. Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with implanted LVAD.
The investigators goal is to include sixty patients with first implanted LVAD in this study over a term of 24 months. After providing written informed consent, randomization into a control group and into a training group will be conducted. All study participants will perform cardiopulmonary exercise testing (CPET) initially before randomization and at the end of the study. The control group will receive the established recommended standard physiotherapeutic treatment, including respiratory supportive therapy, chest muscle mobilization, coordination and stability training as well as walking exercise units. The training group will additionally undergo five spiroergometry- guided training sessions on ergometer per week. Three training sessions will consist of interval training; the other two sessions will consist of endurance training. Interval training hereby consists of training unit of 30 seconds at VO2 peak (maximal oxygen uptake) followed by 60 seconds below the anaerobic threshold (VT1). Endurance training units will consist of training below VT1. Criteria to stop exercise include patient exertion (Borg scale > 14), reduction in LVAD pump flow, pump speed or pump power. Both groups will perform CPET and 6 minute walk test (6 MWT) at study initiation and at study end. The training group will perform CPET including blood gas analysis every two weeks in order to adjust their individual training protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Henrik Fox, MD
- Phone Number: 49 5731 971258
- Email: hfox@hdz-nrw.de
Study Contact Backup
- Name: Astrid Kleemeyer
- Phone Number: 49 5731 971258
- Email: akleemeyer@hdz-nrw.de
Study Locations
-
-
NRW
-
Bad Oeynhausen, NRW, Germany, 32545
- Herz- und Diabeteszentrum NRW
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- new implanted LVAD
- current treatment in Hospital
- hemodynamically stable patients without i.v. ionotropic Treatment
- at hand echocardiogram
- at hand spirometry
- spiroergometry including blood gas analysis.
Exclusion Criteria:
- serious psychologic/ psychiatric disorders
- breastfeeding/ pregnancy
- serious neurologic disorders
- serious comorbidities that would compromise patient compliance
- missing written informed consent
- persistent inotropic therapy
- acute or enduring infections.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in constant work rate exercise time (cwret) at 75% of patients' peak workrate.
Time Frame: 24 months
|
Patients undergo a ramp exercise test up to maximal tolerance.
A second test is performed at constant workrate which equals 75% of the achieved maximal workrate during the ramp test.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in VO2 Peak (ml/min/kg) after training
Time Frame: 24 months
|
A ramp test will be performed at baseline and at the end of the training program.
Changes in weight adapted values (ml/min/kg) will be assessed.
|
24 months
|
Change in VE/VCO2 slope after training
Time Frame: 24 months
|
A ramp test will be performed at baseline and at the end of the training program.
Changes in the Ratio of Minute Ventilation vs. carbon dioxide Output will be assessed
|
24 months
|
Safety of the structured training program
Time Frame: 24 months
|
All adverse and serious Events will be recorded in the training and in the Control Group.
Comparison between Groups will be performed.
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HDZ_KA_016_LKW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States