JPRN-jRCT2052200064招募中3 期
Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB): A multicenter, prospective, randomized, controlled and non-inferiority study - Change in 6 minutes walk distance from the screening to the end of the intervention period**It is not set to be primary outcome for patients with angina pectoris, after open heart surgery, aortic diseases or peripheral arterial disease
Sakata Yasushi0 个研究点目标入组 128 人开始时间: 2020年10月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who are hospitalized with diagnosis of heart failure*a
- •2) Indication of cardiac rehabilitation in outpatient setting
- •3) 6 minutes walk distance for 200m or more and less than 550m*b
- •4) New York Heart Association class 2 or 3*c
- •5) Patients who are age 20 years and over at the day informed consent obtained
- •6) Patients who can obtain document consent with their own will before any study related procedure
- •a)The safety assessment cohort other than heart failure is replaced with angina pectoris, after open heart surgery, aortic disease or peripheral arterial disease
- •b)c) Not applied to patients with angina pectoris, after open heart surgery, aortic disease or peripheral arterial disease
排除标准
- •Primary registration
- •1)Patients who do not have or prepare good net environments at their own home
- •2)Patients with contraindication of exercise
- •3)Patients who can not pedal cycle ergometers due to other diseases or pain
- •4)Patients who have difficulties in using the application of this trial due to vision impairment or hardness of hearing
- •5)Patients who experienced low blood pressure, lethal arrhythmia or other adverse events under cardiac rehabilitation, exercise stress test or exercise treatment
- •6)Patients who are planned to take inpatient cardiac rehabilitation program for 4 weeks and over
- •7)Acute myocardial infarction patients with untreated significant coronary stenosis (75% or more) in the main three branches [American Heart Association: # 1,2,3,5,6,7,11,13]
- •8)Patients who are planned to undergo cardiovascular operation or procedure within 24 weeks from the day obtained informed consent for the treatment
- •9)Patients who are planned to undergo cardiac transplantation within 24 weeks from the day obtained informed consent
- •10)Patients who have been performing intermediate or intensive exercise regularly (once a week or more) within past 6 weeks from the day obtained informed consent
- •11)Advanced heart failure
- •12)End-stage kidney disease (estimated GFR <15 ml/min/1.73m2)
- •13)End-stage liver disease
- •14)Severe Aortic stenosis
- •15)Patients who are suggested to be residual myocardial ischemia
- •16)Uncontrolled heart failure
- •17)Patients who are inplaneted the left ventricular assist device
- •18)Life expectancy would be 6 months and over
- •19)Patients who participate in other clinical trial or clinical study within past 12 weeks before the day obtained informed consent
- •20)Patients who are judged not to be able to follow the significance or observe compliance of this trial due to dementia or mental disorders by the principal investigators or sub investigators
- •21)Patients who are judged to be ineligible to this trial with other reasons by the principal investigators or sub investigators
- •Secondary registration
- •1)Patients who do not have or prepare good net environments at their own home
- •2)Patients who experienced low blood pressure, lethal arrhythmia or other adverse events under cardiac rehabilitation, exercise stress test or exercise treatment
- •3)Patients who took inpatient cardiac rehabilitation program for more than 4 weeks
- •4)Patients who are extended their hospitalization by unexpected reason
- •5)Patients who participated outpatient cardiac rehabilitation program less than 4 times during run-in period
- •6)Patients who are judged to be ineligible to this trial with other reasons by the principal investigators or sub investigators
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