The Feasibility, Safety and Tolerability of an Exercise Training Programme in Patients with Severe Aortic Stenosis Prior to Aortic Valve Replacement Surgery: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility Outcomes
研究概览
简要总结
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement (AVR) in patients with severe aortic stenosis is feasible, safe, and tolerable.
Fitter patients have better surgical outcomes. Exercising post AVR surgery has been well documented and supported through cardiac rehabilitation programmes. However, there is limited evidence investigating exercising patients preoperatively, in part related to safety considerations in patients with severe aortic stenosis. If undertaking a SRETP before AVR in patients with severe aortic stenosis is shown to be feasible and safe, it provides a prehabilitation opportunity to enhance physical fitness with the aim of improving surgical outcomes.
Therefore, this trial will investigate whether SRETP (Prehabilitation) delivered before AVR in patients with severe aortic stenosis is safe & feasible.
详细描述
Single-centre Feasibility trial 15 patients
- Age ≥ 18 years old
- Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- At least 14 days until planned to come in (TCI) date
- Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- Presyncope/syncope due to aortic stenosis
- Unstable angina/indication for urgent surgery
- Malignant arrhythmias
- Known pregnancy
- Patients declining surgery
- Patients weight exceeds 160kg
- Patients unable to give informed consent
Intervention: 1) An in-hospital Structured Responsive Exercise-Training Programme (SRETP). The intervention will be delivered before surgery.
Feasibility Outcomes:
- Adherence to the intervention of ≥75%
- Tolerability of the intervention (minutes completed during the interval training) of ≥75%
- Adverse Events to SRETP
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •INCLUSION CRITERIA
- •Participants may enter the study if ALL of the following apply:
- •Age ≥ 18 years old
- •Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement
- •At least 14 days until planned to come in (TCI) date.
排除标准
- •EXCLUSION CRITERIA
- •Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s
- •Presyncope/syncope due to aortic stenosis
- •Unstable angina/indication for urgent surgery
- •Malignant arrhythmias
- •Known pregnancy
- •Patients declining surgery
- •Patients weight exceeds 160kg
- •Patients unable to give informed consent
- •Currently participating in another interventional clinical trial (although this will be reviewed on a case-by-case basis)
研究组 & 干预措施
An in-hospital Structured Responsive Exercise-Training Programme (SRETP)
Participants will participate in a structured, responsive, exercise training programme (SRETP) on a cycle ergometer. This training programme has been used in numerous international clinical trials, in several patient cohorts including cancer and lung disease.
The training programme will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity. This mode of exercise training is termed aerobic high-intensity interval training (HIIT). Exercise intensities during the interval exercise training program are specific to each participant and will be derived from the CPET. Moderate-intensity exercise is recognised as exercise below the anaerobic threshold. Participants will exercise at 80% of the work rate achieved at the anaerobic threshold (80%AT) for moderate-intensity exercise. High-intensity exercise is recognised as 50% of the difference between the "V" ̇O2 at the anaerobic threshold and the "V" ̇O2 peak (50%∆).
干预措施: Exercise (Other)
结局指标
主要结局
Feasibility Outcomes
时间窗: Baseline up to surgery
1. Adherence to the intervention ≥75% 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75% 3. Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)
次要结局
- Endurance time(Baseline up to surgery)
- Change in objectively measured cardiopulmonary exercise testing variables(Baseline up to surgery)
- Health-related quality of life(Baseline up to surgery)