Exercise Training in Patients With Left Ventricular Assist Device (Ex-VAD)

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: exercise training intervention

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • München, Germany, 80992
    • Klinikum rechts der Isar der Technischen Universität München und Klinikum der Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic end-stage systolic heart failure

• stable on left ventricular assist device, meaning

  1. 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
  2. post implantation ≥ 3 months
  3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to exercise training	accelerometry	up to 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of Leipzig; University Medicine Greifswald; Technical University of Munich; University of Göttingen; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Publications and helpful links

Helpful Links

• Ex-VAD trial website

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: left ventricular assist device; exercise training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Ex-VAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No