The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)
Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
Berlin, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
change in maximal exercise capacity
cardiopulmonary exercise testing (CPET; peakVO2)
Time frame: after 12 weeks of treatment
change in ventilatory efficacy
cardiopulmonary exercise testing (CPET; VE/VCO2 slope)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in submaximal exercise tolerance
6-minute-walk distance (m), anaerobic threshold (VO2 at AT)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in muscle strength
handgrip (kg)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in body composition
% fat mass
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
patient-reported measure of quality of life for patients with heart failure
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
36-Item Short Form Survey (SF-36)
patient-reported measure of health status
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
Patient Health Questionnaire (PHQ-9)
patient-reported measure of presence and severity of depression
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
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Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München
München, Germany
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular ejection fraction (%)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic volume (ml)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
left ventricular end diastolic diameters (mm)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise
tricuspid annular plane systolic excursion (TAPSE; mm)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in markers of neuroendocrine activation
NT-proBNP (ng/l)
Time frame: after 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
physical activity diary
Time frame: up to 12 weeks of treatment and 12 weeks of follow-up
change in daily physical activity
accelerometry
Time frame: up to 12 weeks of treatment and 12 weeks of follow-up