Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Cardiac Energetics
研究概览
简要总结
Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
详细描述
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
- •Participant who is willing and able to give informed consent for participation in the study.
排除标准
- •Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program.
- •Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
- •Any patient who is not able to commit to a 12 week supervised training program.
- •Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
- •Contraindication to magnetic resonance scanning such as an implantable cardiac device.
- •Pregnancy
结局指标
主要结局
Cardiac Energetics
时间窗: At completion of 12 weeks intervention
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
次要结局
- Mental status and Stress(At completion of 12 weeks intervention)
- Left Ventricular Global Longitudinal Strain(At completion of 12 weeks intervention)
- Exercise Capacity(At completion of 12 weeks intervention)