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Completed

NCT Number: NCT03369938

Exercise Training in Patients With Left Ventricular Assist Device

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin und Deutsches Herzzentrum Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training Intervention

Other

structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)

Primary outcomes

  1. change in maximal exercise capacity

    Time frame: after 12 weeks of treatment

    cardiopulmonary exercise testing (CPET; peakVO2)

Secondary outcomes

  1. change in ventilatory efficacy

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    cardiopulmonary exercise testing (CPET; VE/VCO2 slope)

  2. change in submaximal exercise tolerance

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    6-minute-walk distance (m), anaerobic threshold (VO2 at AT)

  3. change in muscle strength

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    handgrip (kg)

  4. change in body composition

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    % fat mass

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    patient-reported measure of quality of life for patients with heart failure

  6. 36-Item Short Form Survey (SF-36)

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    patient-reported measure of health status

  7. Patient Health Questionnaire (PHQ-9)

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    patient-reported measure of presence and severity of depression

  8. change in echocardiographic parameters of cardiac morphology and function at rest and during exercise

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    left ventricular ejection fraction (%)

  9. change in echocardiographic parameters of cardiac morphology and function at rest and during exercise

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    left ventricular end diastolic volume (ml)

  10. change in echocardiographic parameters of cardiac morphology and function at rest and during exercise

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    left ventricular end diastolic diameters (mm)

  11. change in echocardiographic parameters of cardiac morphology and function at rest and during exercise

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    tricuspid annular plane systolic excursion (TAPSE; mm)

  12. change in markers of neuroendocrine activation

    Time frame: after 12 weeks of treatment and 12 weeks of follow-up

    NT-proBNP (ng/l)

  13. change in daily physical activity

    Time frame: up to 12 weeks of treatment and 12 weeks of follow-up

    physical activity diary

  14. change in daily physical activity

    Time frame: up to 12 weeks of treatment and 12 weeks of follow-up

    accelerometry

Other outcomes

  1. adherence to exercise training

    Time frame: up to 12 weeks of treatment

    accelerometry

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Technical University of Munich
  • University Medicine Greifswald
  • University of Göttingen
  • University of Leipzig

Registry information

Acronym: Ex-VAD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2017
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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