Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients willing to undertake cardiac rehabilitation following TAVR.
研究概览
简要总结
The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.
详细描述
BACKGROUND
Aortic stenosis is the most common form of valvular heart disease in the elderly and is associated with high morbidity and mortality once cardiac symptoms develop (1). In patients who are at high risk for serious complications during or after surgery, Transcatheter Aortic Valve Implantation (TAVI) has been shown to result in reductions in mortality and improvement in quality of life compared with medical therapy (2, 3).
Due to the ageing and increasingly complex nature of patients with aortic stenosis, frailty and functional assessment has become a high-priority theme within patient management. Frailty is a term widely used to describe a multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability. Several publications deal with the impact of frailty on mortality and morbidity in the elderly population. Functional status is evaluated by the ability to undertake Activities of Daily Living (ADL) and it has been demonstrated that frailty and the onset of dependence in ADL are strongly associated.
4.2 PRE-CLINICAL DATA/CLINICAL DATA
Cardiac rehabilitation is a complex intervention offered to patients with heart disease and includes components of health education, advice on cardiovascular risk reduction, physical activity and stress management. Cardiac rehabilitation and physical activity are recommended treatments after cardiac valve surgery and positively improves morbidity, exercise capacity and quality of life or emotional well-being. The National Institute for Healthcare Excellence and The Department of Health and wider European guidelines agree that patients who have received heart valve replacements will benefit from cardiac rehabilitation.
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
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic aortic stenosis accepted for Trans Catheter Aortic Valve Replacement
- •Age ≥75 years;
- •Participant able and willing to give written informed consent;
- •Participant able (in the Investigator's opinion) and willing to comply with all study requirements.
排除标准
- •Subjects may not enter the study if ANY of the following apply:
- •Intervention deemed inappropriate due to co-morbidity or frailty;
- •Life expectancy less than one year due to co-morbidity;
- •Previous AVR or TAVI;
- •Predominant aortic regurgitation (AR).
研究组 & 干预措施
Cardiac Rehabilitation
Patients will return to the out-patient clinic at 4 weeks post - TAVR and research consent will be re-affirmed. Patients will be randomised to receive a programme of cardiac rehabilitation or routine care at this point. Patients randomised to receive cardiac rehabilitation will meet the cardiac rehab team and undergo baseline assessment for the programme. This involves recording height, weight, blood pressure, oxygen saturation and heart rate and rhythm. An individualised programme will be established to meet the needs of each patient. The patients will undergo a 6 week programme of cardiac rehab. Patients who are not allocated to the intervention group will not receive a cardiac programme and will have access to the TAVR nurse specialist team as would be usual care.
干预措施: Cardiac Rehabilitation (Other)
Standard of care
15 patients will be randomised to receive a programme of cardiac rehabilitation, and 15 patients will receive standard of care which does not include a routine rehabilitation programme.
结局指标
主要结局
Proportion of patients willing to undertake cardiac rehabilitation following TAVR.
时间窗: 6 months
次要结局
- Functional capacity by 4 metre gait speed.(6 months)
- Frailty assessment via the FRIED criteria.(6 months)
- Hospital Anxiety and Depression score(6 months)