Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Physical activity derived from the International Physical Activity questionnaire (IPAQ)
研究概览
简要总结
Cardiac rehabilitation after an acute coronary syndrome is recognised in the latest guidelines and recommendations published by the major scientific societies as a class I indication. Despite this evidence, the number of patients entering such programmes in Europe is still around 30%. The present study aims to validate a new comprehensive Telerehabilitation System to provide support for cardiac rehabilitation, to optimize it and to test its usefulness in terms of improving adherence to physical exercise and cardiovascular risk parameters.
详细描述
To validate this approach, a clinical trial was designed to compare a 10-month program of cardiac telerehabilitation with a conventional 8-week centre-based cardiac rehabilitation. Seventy patients will be randomized 1:1 to cardiac telemonitoring or centre-based cardiac rehabilitation. The characteristics of the interventions do not allow the study to be blinded to the patient or the professional. However, the analyses, stress tests and questionaires will be carried out in a masked form without the assigned group being identified by the researchers carrying out the examinations. Assessment for primary and main secondary outcomes will be performed at baseline and at ten months of follow-up, and will include self-reported physical activity (IPAQ), VO2max, blood test, general emotional distress, Adherence to the Mediterranean Diet, quality of life, vital signs, returning to work. The hypothesis is that patients randomised to prolonged telemonitoring will demonstrate higher levels of physical activity at 10-month follow-up, compared to patients in the centre-based cardiac rehabilitation programme, as well other positive changes in the cardiovascular risk profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses, stress tests and shuttle tests will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients after uncomplicated acute coronary syndrome of both sexes.
- •Patients completing a maximal or symptom-limited CPET without angina or electrical ischaemia.
- •Age equal to or less than 72 years.
排除标准
- •Refusal of informed consent
- •Advanced biological age.
- •Kidney failure (GFR < 30ml/min/1.73 m2).
- •Liver failure (GOT >2 times normal value).
- •Ejection fraction less than 50%.
- •Uncontrolled blood pressure (>140/90 mmHg).
- •Uncontrolled heart failure.
- •Dissecting aortic aneurysm.
- •Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
- •Aortic or mitral valve disease.
- •Recent systemic or pulmonary embolism.
- •Active or recent thrombophlebitis.
- •Acute infectious diseases.
- •Uncontrolled supraventricular arrhythmias or tachycardia.
- •Repeated or frequent ventricular ectopic activity.
- •Moderate pulmonary hypertension.
- •Ventricular aneurysm.
- •Uncontrolled diabetes, thyrotoxicosis, myxedema,
- •Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
- •Wolf-Parkinson-White syndrome.
- •Fixed rate pacing.
- •Severe anaemia.
- •Psychoneurotic disorders.
- •Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
结局指标
主要结局
Physical activity derived from the International Physical Activity questionnaire (IPAQ)
时间窗: 10 months
self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
次要结局
- Visceral fat(4 and 10 months)
- Returning to work(10 months)
- Pulse wave velocity(10 months)
- Maximal oxygen uptake(10 months)
- Glycosylated haemoglobin(10 months)
- Weight(4 and 10 months)
- Maximal heart rate(10 months)
- Exercise time(10 months)
- Lipid parameters(10 months)
- Waist circumference(4 and 10 months)
- energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire(10 months)
- Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).(10 months)
- High level of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED)(10 months)
- High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire(10 months)
- Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)(10 months)
- User's experience from the System Usability Scale (SUS) score(10 months)
- Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)(10 months)
- Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)(10 months)
- smoking cessation(10 months)
- Time to start the rehabilitation programme after discharge from hospital(10 months)
- Cost-effectiveness analysis(10 months)