Exercise Training in Patients With Left Ventricular Assist Device

Charite University, Berlin, Germany5 个研究点分布在 1 个国家目标入组 64 人2017年12月4日

适应症Heart Failure

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Heart Failure
发起方: Charite University, Berlin, Germany
入组人数: 64
试验地点: 5
主要终点: change in maximal exercise capacity
状态: 已完成
最后更新: 5年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).

注册库

clinicaltrials.gov

开始日期

2017年12月4日

结束日期

2020年12月31日

最后更新

5年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Charite University, Berlin, Germany

责任方

Principal Investigator

主要研究者

Univ.-Prof. Dr. med. Frank Edelmann

Professor for Cardiovascular Prevention and Clinical Heart Failure Research

Charite University, Berlin, Germany

入排标准

入选标准

•chronic end-stage systolic heart failure
•stable on left ventricular assist device, meaning
•no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks
•post implantation ≥ 3 months
•expected further period on the device for a minimum of 3 months after recruitment into the study
•ability to complete the study in compliance with the protocol.
•general ability of the patient to declare willingness to participate in the trial.
•written informed consent

排除标准

•acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke
•untreated life-threatening cardiac arrhythmias
•uncontrolled hypertension
•intracardiac thrombus
•inability to perform cardiopulmonary exercise testing at least 1 minute at 20W
•uncontrolled diabetes
•uncontrolled kidney disease
•recent embolism
•concurrent, continuous, or intermittent dobutamine therapy
•complex ventricular arrhythmia at rest or appearing with exertion

结局指标

主要结局

change in maximal exercise capacity

时间窗: after 12 weeks of treatment

cardiopulmonary exercise testing (CPET; peakVO2)

次要结局

change in submaximal exercise tolerance(after 12 weeks of treatment and 12 weeks of follow-up)
change in muscle strength(after 12 weeks of treatment and 12 weeks of follow-up)
change in body composition(after 12 weeks of treatment and 12 weeks of follow-up)
Kansas City Cardiomyopathy Questionnaire (KCCQ)(after 12 weeks of treatment and 12 weeks of follow-up)
36-Item Short Form Survey (SF-36)(after 12 weeks of treatment and 12 weeks of follow-up)
Patient Health Questionnaire (PHQ-9)(after 12 weeks of treatment and 12 weeks of follow-up)
change in echocardiographic parameters of cardiac morphology and function at rest and during exercise(after 12 weeks of treatment and 12 weeks of follow-up)
change in daily physical activity(up to 12 weeks of treatment and 12 weeks of follow-up)
change in markers of neuroendocrine activation(after 12 weeks of treatment and 12 weeks of follow-up)
change in ventilatory efficacy(after 12 weeks of treatment and 12 weeks of follow-up)