Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- peak VO2, measured during an effort test
研究概览
简要总结
Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical capacity, accelerating return to activities and reinsertion and reducing mortality. It associates reconditioning to effort and therapeutic education for the optimal control of " risk factors ". It corresponds to a global approach to patients, thus counterbalancing the tendency to hyperspecialise in medicine. However, because of the lack of specialised centres, only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in e-health, the deployment of the Internet and certain " connected " devices may provide alternatives outside hospital, by enabling the follow-up of patients and their physiological parameters (heart rate, blood pressure, weigh, physical activity...), and the adaptation - using an interactive web platform - of the physical activity programme, nutrition, compliance with medication and weaning from smoking. This project proposes to evaluate the effects of a so-called " connected " CVR programme, and to show its non-inferiority compared with a conventional CVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women,
- •aged between 30 and 75 years,
- •presenting coronary artery disease without heart failure (Left ventricular ejection fraction on echocardiography (Simpson method) > 45 %).
- •Patients who have provided written consent.
排除标准
- •Adults under guardianship
- •Patients without national health insurance cover
- •Pregnant or breastfeeding women
- •Inability to use connected numeric devices even simple operations (tablette, cardiofrequency meter, BP monitor...)
- •Heart failure, with a low or preserved left ventricular ejection fraction
- •Contra-indication for cardiovascular rehabilitation :
- •Severe obstructive heart disease (severe and asymptomatic obstacle to left ventricular ejection)
- •Acute unstable coronary syndrome
- •Tight aortic valve stenosis
- •Severe progressive cardiac rhythm or conduction disorders without pacing and discovered during the initial stress test
- •Intracavitary thrombus
- •Presence of moderate to severe pericardial effusion
- •Severe pulmonary artery hypertension (systolic PAP >70mmHg)
- •Recent history of venous thromboembolism (previous 3 months)
- •Progressive inflammatory or infectious disease
- •Inability to engage in physical exercise
- •Impaired executive functions making it impossible to understand and comply with the CVR programme (Mini Mental Test < 24)
- •Heart transplant
- •Associated medical condition likely to impair functional capacities (examples: non-stabilised metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilised disorder such as neoplasm, systemic diseases...)
- •Physical disability in the lower limbs that could hamper reconditioning, whether neurological (central or peripheral), arterial (in particular, peripheral artery disease with a systolic index < 0.6) or orthopaedic (degenerative or inflammatory rheumatism)
研究组 & 干预措施
Conventional CVR
干预措施: Conventional CVR programme (Other)
Conventional CVR
干预措施: Follow-up visit M2 (Other)
Conventional CVR
干预措施: Follow-up vsit M8 (Other)
eCVR
干预措施: Connected CVR programme (Other)
eCVR
干预措施: Follow-up visit M2 (Other)
eCVR
干预措施: Follow-up vsit M8 (Other)
结局指标
主要结局
peak VO2, measured during an effort test
时间窗: Month 2
次要结局
未报告次要终点