The Effect of a Physiotherapy Prehabilitation Programme on Postoperative Outcomes in Patients Undergoing Cardiac or Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.
研究概览
简要总结
The purpose of this study is to determine the effects of a physiotherapy prehabilitation programme (walking and deep breathing exercises) in cardiac or thoracic patients by measuring changes in lung volumes, functional capacity physiotherapy length of stay postoperatively.
详细描述
Preoperative rehabilitation or "Prehabilitation" can be defined as "the process of enhancing the functional capacity of the individual to enable him or her to withstand a stressful event". Prehabilitation is a relatively new concept with emerging evidence demonstrating a reduction in length of hospital stay and disability, improved functional capacity and quality of life as well as fewer peri-operative complications compared to usual care.
Patients who are awaiting Cardiothoracic surgery are often fearful of being physically active, however extended periods of physical inactivity lead to a loss of muscle mass, physical deconditioning and pulmonary complications which can in turn lead to decreased quality of life, higher levels of morbidity, increased hospital length of stay and even fatality.
Based on literature supporting the positive effects of physical activity, physiotherapy prehabilitation aims to enhance functional exercise capacity in patients undergoing Cardiothoracic surgery and hence minimising the risk of postoperative morbidity and enhancing postsurgical recovery. Although there is evidence for prehabilitation in cardiothoracic specialties these are mainly within heart failure patients therefore not comparable to patients undergoing CABG or lobectomy surgeries.
The aim of this study is to determine whether a home based preoperative prehabilitation programme improves patients' functional capacity, as measured by a 6 minute walk test (6MWT) prior to surgery and improve post surgical recovery and recovery of functional capacity earlier. This study will compare functional capacity levels from baseline (at time of being accepted for surgery) and on the day of admission for surgery. Secondary aims are to determine functional capacity prior to discharge from hospital and at 6-8 week follow up appointment. Increasing maximal tidal volumes preoperatively would in turn decrease the chance of atelectasis postoperatively thereby decreasing pulmonary complications. Time to achieve discharge criteria from physiotherapy and total post-operative hospital length of stay will be assessed. Patient health related satisfaction will be assessed using the EQ-5D. The endpoint of this study will be when the patient returns for their routine 6-8 week follow up appointment and completes final 6MWT, tidal volume (TV) measurement and EQ-5D.
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
- Single (Investigator)
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
- •Cardiac surgery -
- •Patients undergoing primary CABG surgery
- •Age >18 years old
- •Able to mobilise independently with/without a walking aid
- •Thoracic surgery -
- •Patients undergoing lobectomy surgery
- •Age >18 years old
- •Able to mobilise independently with/without a walking aid
排除标准
- •Cardiac surgery -
- •Unstable angina (Grade IIIb as described in Braunwald Classification of Unstable Angina/ angina at rest within the last 48 hours)
- •History of cerebrovascular accident (CVA)
- •History of traumatic brain injury (TBI)
- •Patients who require interpreter
- •Falls risk as classified by the GJNH falls risk document
- •Patients included within cardiac surgery ERAS programme
- •Any patient who lacks capacity to consent
- •Patients who are admitted for urgent or emergency cardiac surgery e.g. aortic stenosis
- •Thoracic surgery -
- •Unstable angina (Grade IIIb as described in Braunwald Classification of Unstable Angina/ angina at rest within the last 48 hours)
- •History of cerebrovascular accident (CVA)
- •History of traumatic brain injury (TBI)
- •Patients who require interpreter
- •Falls risk as classified by the GJNH falls risk document
- •Any patient who lacks capacity to consent
- •Patients who are admitted for urgent or emergency surgery
研究组 & 干预措施
Prehabilitation
This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.
干预措施: Walking Programme (Other)
Prehabilitation
This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.
干预措施: Incentive Spirometer (Device)
Prehabilitation
This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.
干预措施: Deep Breathing Exercises (Other)
Standard Care
This group will receive standard preoperative information and education only.
结局指标
主要结局
Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.
时间窗: From date of randomisation to date of admission for surgery (up to 8 weeks)
The 6MWT is a validated test that requires no exercise equipment or "advanced" training for the assessor. Walking is an activity carried out on a daily basis by most people. The 6MWT measures the distance that a person can walk on a flat surface over a period of 6 minutes. The majority of activities of daily living are carried out at "sub-maximal" levels similar to the level of exertion of the 6MWT as the patient sets their own intensity (American Thoracic Society 2002). A review of functional walking tests suggested that "the 6MWT is easy to administer, better tolerated, and more reflective of activities of daily living than the other walk tests" (Solway et al 2001). Other prehabilitation studies have used the 6MWT as an outcome measure of functional activity therefore is widely accepted as a reliable measure of functional activity (Sawatzky et al 2014; Carli et al 2010; Gillis et al 2014).
次要结局
- EQ-5D score.(At baseline and follow up clinic appointment (up to 8 weeks).)
- Functional capacity as measured by 6MWT on day of discharge and at return clinic appointment (up to 8 weeks)(Date of discharge from physiotherapy and at return clinic appointment (up to 8 weeks))
- Tidal Volume (TV) measures with incentive spirometer.(At baseline, preoperative, postoperative days 1, 2 and 3 and at return clinic appointment (up to 8 weeks))
- Day of discharge from Physiotherapy.(Once all physiotherapy criteria have been met (approximately 3 to 5 days).)
- Total postoperative hospital length of stay.(Once all hospital discharge criteria have been met (approximately 5-7 days).)