Effect of Implant-based Telerehabilitation in Patients With Heart Failure on Daily Physical Activity, Quality of Life and Exercise Capacity (TELE-RCT Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Increase in percentage active minutes per day measured by CRT device
研究概览
简要总结
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients with an implanted CRT device in Jessa Hospital Hasselt in Belgium.
详细描述
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients with an implanted CRT device in Jessa Hospital Hasselt in Belgium. Subjects that do not violate any of the exclusion criteria and that have provided informed consent, will be asked to participate in the study. Patients that enter the study will be randomly assigned in a 1:1 ratio to the intervention or control group. Given the nature of the study, no blinding can be applied.
A cardiac resynchronization therapy (CRT) device is a battery operated device consisting of a pulse generator and thin, insulated wires called leads. The device sends electrical impulses throughout the heart to improve pump activity. This is particularly helpful in patients suffering from chronic heart failure, given that the pump activity in these patients is compromised.
Two types of CRT devices exist. On one hand a cardiac resynchronization therapy defibrillator (CRT-D), which functions as a normal pacemaker but can also sense arrythmias that can lead to sudden cardiac arrest. The device recognizes these arrhythmias and generates a defibrillation to stop the abnormal rhythm. On the other hand a cardiac resynchronization therapy pacemaker (CRT-P), which only functions as a pacemaker.
b. Study population
In order to be enrolled in the TELE-RCT study, subjects must meet all of the following inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •- Patients with an implanted CRT-D or CRT-P device in which monitoring of physical activity is possible
- •CRT device must be implanted for at least three months
- •Dutch speaking and understanding
- •Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
- •Age ≥ 18 years
- •CRT capable of transmitting data about physical activity in an interpretable manner
- •Willingness and physically able to follow an email-based or SMS-based telemonitoring program and other study procedures in a 12 weeks follow-up period.
- •Clinically stable without inducible ischemia or high-risk ventricular arrhythmia, confirmed by the last available maximal ergo-spirometry test
- •Possession of smartphone or email address, which the patients regularly check, in order to receive feedback from the research staff
排除标准
- •The presence of an absolute or relative contraindication to moderate- intensity exercise
- •Participation in a cardiac revalidation program in the months before enrollment in the study
- •Patients with planned interventional procedure or surgery in next three months
- •Present cardiovascular complaints that might interfere with exertion: unstable angina, recent ICD shock etc.
- •Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
- •Orthopedic, neurologic, or any other pathologic condition that makes the patient physically unable to follow an email-based or SMS-based telemonitoring program
- •Any condition, which, in the opinion of the investigator, would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigator's judgment
结局指标
主要结局
Increase in percentage active minutes per day measured by CRT device
时间窗: 12 weeks
次要结局
- International Physical Activity Questionnaire(12 weeks)
- HeartQol questionnaire(12 weeks)
- Satisfaction: questionnaire(12 weeks)
- SUS questionnaire(12 weeks)
研究者
prof. dr. Paul Dendale
Prof. Dr.
Hasselt University