Exercise Training in Patients With Left Ventricular Assist Device

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Exercise Training in Patients With Left Ventricular Assist Device

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: exercise training intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic end-stage systolic heart failure stable on left ventricular assist device, meaning no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks post implantation ≥ 3 months expected further period on the device for a minimum of 3 months after recruitment into the study ability to complete the study in compliance with the protocol. general ability of the patient to declare willingness to participate in the trial. written informed consent Exclusion Criteria: acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke untreated life-threatening cardiac arrhythmias uncontrolled hypertension intracardiac thrombus inability to perform cardiopulmonary exercise testing at least 1 minute at 20W uncontrolled diabetes uncontrolled kidney disease recent embolism concurrent, continuous, or intermittent dobutamine therapy complex ventricular arrhythmia at rest or appearing with exertion supine resting heart rate > 100 beats per minute severe pulmonary instability hemodynamically relevant valvular disorders significant change in cardiovascular medication within the previous 4 weeks (see inclusion criteria) severe anemia (hemoglobin <8 g/dl), however patients with moderate anemia (hemoglobin <11 g/dl) may be recruited if clinically stable (investigator assessment) clinically relevant musculoskeletal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise training intervention<br> | Other: exercise training intervention<br>* structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maximal exercise capacity | cardiopulmonary exercise testing (CPET; peakVO2) | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in ventilatory efficacy | cardiopulmonary exercise testing (CPET; VE/VCO2 slope) | 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) | after 12 weeks of treatment and 12 weeks of follow-up | 
| change in muscle strength | handgrip (kg) | after 12 weeks of treatment and 12 weeks of follow-up | 
| change in body composition | % fat mass | 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 | after 12 weeks of treatment and 12 weeks of follow-up | 
| 36-Item Short Form Survey (SF-36) | patient-reported measure of health status | 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 | 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 ejection fraction (%) | 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) | 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) | 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) | after 12 weeks of treatment and 12 weeks of follow-up | 
| change in markers of neuroendocrine activation | NT-proBNP (ng/l) | after 12 weeks of treatment and 12 weeks of follow-up | 
| change in daily physical activity | physical activity diary | up to 12 weeks of treatment and 12 weeks of follow-up | 
| change in daily physical activity | accelerometry | up to 12 weeks of treatment and 12 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left ventricular assist device, exercise training