Influence of Individualized Training on Cardiopulmonary Exercise Capacity in LVAD Patients
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|ClinicalTrials.gov Identifier: NCT03984162|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
|Condition or disease|
b.) Current European guidelines for prevention of cardiovascular disease recommend regular training for patients suffering from any cardiovascular disease. Studies have shown that regular training results in an improvement of cardiopulmonary exercise capacity. Objective parameters such as peak VO2 and VE/ VCO2 slope can be positively influenced by training in patients with heart failure. Only few studies suggest a beneficial impact on exercise capacity in patients with an implanted ventricular assist device (LVAD), but literature on this topic is scarce. So far there are no recommendations for a standardized exercise protocol for LVAD.
The aim of this prospective monocentric study is to examine the influence of an individualized, spiroergometry- guided training protocol on cardiopulmonary fitness in patients with an implanted LVAD. Secondary endpoints are to establish an individualized but standardized and clinically safe training protocol for patients with implanted LVAD.
The investigators goal is to include sixty patients with first implanted LVAD in this study over a term of 24 months. After providing written informed consent, randomization into a control group and into a training group will be conducted. All study participants will perform cardiopulmonary exercise testing (CPET) initially before randomization and at the end of the study. The control group will receive the established recommended standard physiotherapeutic treatment, including respiratory supportive therapy, chest muscle mobilization, coordination and stability training as well as walking exercise units. The training group will additionally undergo five spiroergometry- guided training sessions on ergometer per week. Three training sessions will consist of interval training; the other two sessions will consist of endurance training. Interval training hereby consists of training unit of 30 seconds at VO2 peak (maximal oxygen uptake) followed by 60 seconds below the anaerobic threshold (VT1). Endurance training units will consist of training below VT1. Criteria to stop exercise include patient exertion (Borg scale > 14), reduction in LVAD pump flow, pump speed or pump power. Both groups will perform CPET and 6 minute walk test (6 MWT) at study initiation and at study end. The training group will perform CPET including blood gas analysis every two weeks in order to adjust their individual training protocol.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Influence of Individualized, Spiroergometry Guided, Structural Training on Cardiopulmonary Exercise Capacity in Patients With a Left Ventricular Assist Device|
|Estimated Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||July 2021|
- Change in constant work rate exercise time (cwret) at 75% of patients' peak workrate. [ Time Frame: 24 months ]Patients undergo a ramp exercise test up to maximal tolerance. A second test is performed at constant workrate which equals 75% of the achieved maximal workrate during the ramp test.
- Change in VO2 Peak (ml/min/kg) after training [ Time Frame: 24 months ]A ramp test will be performed at baseline and at the end of the training program. Changes in weight adapted values (ml/min/kg) will be assessed.
- Change in VE/VCO2 slope after training [ Time Frame: 24 months ]A ramp test will be performed at baseline and at the end of the training program. Changes in the Ratio of Minute Ventilation vs. carbon dioxide Output will be assessed
- Safety of the structured training program [ Time Frame: 24 months ]All adverse and serious Events will be recorded in the training and in the Control Group. Comparison between Groups will be performed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984162
|Contact: Henrik Fox, MD||49 5731 email@example.com|
|Contact: Astrid Kleemeyer||49 5731 firstname.lastname@example.org|