Exercise Training in Patients With Left Ventricular Assist Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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exercise training intervention

Group Type EXPERIMENTAL

exercise training intervention

Intervention Type OTHER

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

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise training intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No