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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05121077
Other study ID # 21-10169-BO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2021
Est. completion date October 1, 2022

Study information

Verified date October 2022
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Uniklinikum Essen Essen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

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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