Heart Failure Clinical Trial
— TrainLVADOfficial 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
Verified date | October 2022 |
Source | University Hospital, Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 1, 2022 |
Est. primary completion date | September 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Uniklinikum Essen | Essen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min] | 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 | 6 weeks | |
Secondary | Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. | 6 weeks |
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