TELE - WEAR: a Multi - Centre, Blinded, Randomized Controlled Trial Investigating the Efficacy, Efficiency and Cost - Effectiveness of a Cardiac Telerehabilitation Program Using Wearable Sensors (TELE - WEAR). Rationale and Study Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in the levels of physical fitness
研究概览
简要总结
Objective: To evaluate the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors
Design: Supervised single-blinded randomized controlled trial, comparing three groups, with follow-ups at baseline, 12 weeks (completion of the intervention), 6 months after the completion of the intervention
Setting: cardiac rehabilitation centres, patients home environments Participants: A total of 102 cardiac patients, regardless sex, aged 18 years and older were randomly assigned to a telerehabilitation group (n = 34), a centre - based cardiac rehabilitation group(n=34) and a usual care control group (n = 34).
Interventions: Exercise - based cardiac rehabilitation program for the intervention groups (both in cardiac clinics' settings and in patients' homes) consisted of three sessions each week for 12 consecutive weeks. The control group received no exercise intervention.
Measurements: Main outcome was measured by Cardiopulmonary Exercise Testing. Secondary outcomes were measured by accelerometry and the use of proper questionnaires.
详细描述
Methods Research design
A supervised, single - blind, randomized controlled trial design will be used to examine the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors. The study was approved by the ethics committee of University of Thessaly.
Sample One hundred and two (102) cardiac patients will be recruited from cardiac rehabilitation centres. Subject eligibility criteria are: a) 18 years of age and older b) diagnosis of stable cardiovascular diseases, acute coronary syndrome, coronary artery bypass grafting within the previous six months c) ability to perform physical exercise d) ability to understand and write in the Greek language e) possession of a mobile smartphone and access to internet facilities.
Assessments Study data will be collected at baseline, the completion of the intervention period (12 weeks follow - up) and 6 months after the completion of the intervention (long - term follow - up)
Procedure
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
- Single (Investigator)
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
- •adults aged ≥18 years
- •stable cardiovascular disease ; acute coronary syndrome; coronary artery bypass grafting within the previous six months
- •ability to perform physical exercise,
- •to speak, read and write Greek
- •possession of a mobile phone/smartphone
- •internet access at home
排除标准
- •ventricular arrhythmia or myocardial ischemia during low to moderate exercise intensity as assessed by symptom limited exercise testing at baseline
- •heart failure New York Heart Association (NYHA) class IV
- •comorbidity precluding exercise training (e.g. orthopaedic, neurological or cognitive conditions)
- •acute myocardial infarction (within two days)
- •unstable angina
- •uncontrolled atrial or ventricular arrhythmia
- •aortic uncontrolled congestive heart failure
- •acute pulmonary embolism
- •acute myocarditis or pericardial effusion
- •uncontrolled diabetes mellitus (Type I, II)
- •hemodynamic instability or exercise-induced arrhythmia in baseline (initial) assessment
- •severe obstructive respiratory disease
研究组 & 干预措施
Telerehabilitation group
Participants will undertake the first three training sessions in the outpatient clinic under the supervision of the specialized staff for familiarization with the intervention. and then the participants will proceed with the telerehabilitation program at their homes. Participants will undergo an exercise - based program 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down, with the use of wearable sensors.
干预措施: Telerehabilitation group (Other)
Centre - based rehabilitation group
Participants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down.
干预措施: Centre - based rehabilitation group (Other)
Usual care group
Patients will not undertake any exercise based intervention and will only follow their usual medication treatment .The patients will wear the accelerometer for the 12 week study duration and visit the corresponding outpatient cardiac clinic every 4 weeks to upload the recorded data. The patients will also receive educational phone videoconference sessions every week for physical activity, diet/nutritional and smoking cessation counseling.
结局指标
主要结局
Change in the levels of physical fitness
时间窗: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Physical fitness will be assessed in all study groups by peak oxygen uptake, determined by cardiopulmonary exercise testing (CPET) with respiratory gas analysis at the outpatient clinic.
次要结局
- Change in the Quality of participants' lives(Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)
- Cost - effectiveness(12 week follow up)
- Change in the levels of physical activity(12 week follow - up (end of intervention), 6 months after the completion of the intervention)
- Adherence to rehabilitation program(12 week follow up)
- Change in the smoking behaviour(Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)
- Change in the levels of anxiety and depression(Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)
研究者
Garyfallia Pepera
Clinical Professor
University of Thessaly