Interval Versus Continuous Training in LVAD Patients (TrainLVAD)

University Hospital Essen

Status: Completed

Conditions: Heart Failure

Treatments: Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05121077

21-10169-BO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Moderate continuous training

Experimental group

Description:

Participants will continuously exercise at a workload between 50-60% of VO2peak on a bicycle ergometer.

Treatment:

Other: Training

Interval training

Experimental group

Description:

Participants will exercise at a varying workload between 50-60% of VO2peak during recovery and 80-90% of VO2peak during bouts of interval training on a bicycle ergometer.

Treatment:

Other: Training