Interval Versus Continuous Training in LVAD Patients

NCT ID: NCT05121077

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2022-10-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate continuous training

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

Group Type: EXPERIMENTAL

Training

Intervention Type: OTHER

2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.

Interval training

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.

Group Type: EXPERIMENTAL

Training

Intervention Type: OTHER

2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.

Interventions

Training

2 types of training intervention will be applied in terminal heart failure patients supported with a left ventricular assist device.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Peter Lüdike

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Lüdike, Prof.

Role: PRINCIPAL_INVESTIGATOR

Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie

Locations

Uniklinikum Essen

Essen, , Germany

Countries

Germany

Other Identifiers

21-10169-BO

Identifier Type: -

Identifier Source: org_study_id