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临床试验/NCT05121077
NCT05121077已完成不适用

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

University Hospital, Essen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Improvement of peak oxygen uptake (VO2peak) in cardiopulmonary exercise testing (CPET) [ml/kg/min]

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age>18 years
  • clinically stable LVAD patients with terminal heart failure
  • written informed consent
  • the mental and physical ability to exercise

排除标准

  • established contraindications for exercise testing
  • systemic blood stream infection

结局指标

主要结局

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

时间窗: 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

次要结局

  • Improvement in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(6 weeks)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Lüdike

Prof.

University Hospital, Essen

研究点 (2)

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