Tele - Cardiac Rehabilitation - Providing Pre-habilitation to Stable Patients With Valvular Heart Disease Awaiting Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- Change in METS
研究概览
简要总结
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
详细描述
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise, dietary intervention, secondary prevention by pharmacotherapy, and psychological intervention. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions (6-8 weeks in accordance with the date of surgery determined for the patient.) Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. Small studies have demonstrated possible benefits of pre-habilitation - a multidisciplinary intervention aimed at improving frailty in the weeks prior to surgery.
We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery.
Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.
The primary efficacy outcome will be exercise capacity (assessed by symptom limited stress test - estimated METS) change from baseline (enrollment) to pre-surgery evaluation visit (pre-op test).
Secondary measures:
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must meet all the following inclusion criteria during the initial screening visit of the study (visit 1):
- •Valvular heart disease and planed surgery within the next 4-12 weeks
- •Smartphone with internet connection
- •Willing and able to comply with study protocol and
- •Able to follow the personalized exercise prescription, utilize Polar watch and upload exercise data per protocol
排除标准
- •Eligible patients must meet none of the following exclusion criteria:
- •Advanced Heart failure (NYHA >3) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- •Significant neurological or cognitive impairment
- •Women of child-bearing potential
- •Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms
- •ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
- •Inability to perform a stress test due to physical limitations
- •Severe angina pectoris as defined by CCS >2
- •Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung involvement) or chronic pulmonary thromboembolic disease (CTED)
- •Severe orthopedic limitations not permitting exercise
- •Active myocarditis, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy
- •Significant anemia (Hb < 9 mg/dl)
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
- •Any illness which reduces life expectancy to less than 1 year from screening
结局指标
主要结局
Change in METS
时间窗: 6-8 weeks
Exercise capacity change as assessed by stress test
次要结局
- ICU duration(2 weeks peri-op)
- Hospitalisation duration(2 weeks peri-op)
- Peri operative complication(2 weeks peri-op)
研究者
Dr. Robert Klempfner Heart Rehabilitation Institute
Prof. Klempfner
Sheba Medical Center