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OpenTrials
Completed

NCT Number: NCT05121077

Interval Versus Continuous Training in LVAD Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinikum Essen

Essen, 45147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Training

Other

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

Primary outcomes

  1. Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min]

    Time frame: 6 weeks

    Improvement of VO2peak in CPET after a training period of 6 weeks. CPET will be performed before (t0) and after (t1) the training period. A significant improvement from t0 to t1 is considered to be an increase of at least 2,5ml/kg/min

Secondary outcomes

  1. Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 6 weeks

    Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Points range from 0 to 100 in each of four domains. The total score is the average of all domains, with higher values depicting better quality of life.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study 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

Acronym: TrainLVAD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2021
Registry last updated
Oct 7, 2022

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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