Clinical trial NCT05121077: Interval Versus Continuous Training in LVAD Patients
Official title: A Prospective, Comparative Analysis of Moderate-continuous (MCT) and Interval Training (IT) in LVAD (Left Ventricular Assist Device) Patients With Terminal Heart Failure: Train the LVAD Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Exercise capacity
VO2peak
Interval training
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either the MCT or IT training group
Primary purpose: TREATMENT

Brief summary: Patients with a left ventricular assist device (LVAD) will be randomized to either a moderate continuous (MCT, 50-60% of VO2peak) or interval training (IT, 80-90% of VO2peak) group for 6 weeks with 3 sessions per week, lasting for 20 minutes. An additional 10 minutes of resistance training will be performed in each group. Improvement of VO2peak and quality of life (KCCQ score) between the groups will be assessed.

Detailed description: In- and out-patients with left ventricular assist device (LVAD) will be recruited to participate. On consent to participate, patients will be randomized to either moderate continuous (MCT) or interval (IT) training. An initial cardiopulmonary exercise test (CPET) will be performed to assess exercise intensity levels using a ramp protocol. Baseline quality of life (KCCQ score), echocardiographic and LVAD parameters, lab works, including NTproBNP, a 6min walk distance (6 MWD) will be assessed. Patients will then receive 6 weeks of supervised training in our facility (3x/week, 30min each). Following these sessions CPET, lab works, KCCQ assessment, 6 MWD, and echocardiography will be performed to assess improvement of exercise capacity.

Patients in the MCT group will receive 20min of moderate, continuous bicycle training at an intensity of 50-60% of VO2peak, the IT group will increase exercise density by increasing the duration of intense bouts (80-90% of VO2peak) over the weeks. All groups will receive an additional 10 minutes of resistance training (total exercise time 30 minutes in both groups). Improvement of VO2peak and quality of life (KCCQ score) between the groups will be assessed.

Eligibility criteria: Inclusion Criteria:

* age\>18 years
* clinically stable LVAD patients with terminal heart failure
* written informed consent
* the mental and physical ability to exercise

Exclusion Criteria:

* established contraindications for exercise testing
* systemic blood stream infection

Primary outcomes:
measure: Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min]
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Uniklinikum Essen
Study officials:
affiliation: Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie
name: Peter Lüdike, Prof.
role: PRINCIPAL_INVESTIGATOR
References: