Prospective Single-centre Randomized Controlled Trial to Evaluate Preoperative Home-based Supervised Exercise Program for Prehabilitation of Frail Elderly Patients Undergoing Major Abdominal Surgery, Against Current Home-based Unsupervised Exercise Program.
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.
研究概览
简要总结
Singapore's population is ageing, and more elderly people are undergoing elective major surgeries. Frail elderly experience greater functional decline and slower recovery in physical function after surgery compared to non-frail elderly. Preoperative prehabilitation aims to enhance both aerobic capacity and physical strength of elderly to attenuate the post-operative decline in physical function. Singapore General Hospital has a bespoke preoperative program - Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE), where patients receive physiotherapy education and instructions for home-based unsupervised exercise program (uSEP). A hospital-based supervised exercise program had also been established but the take-up rate was low (7.6%) due to barriers such as cost and accessibility. Perioperative supervised exercise training can effect greater gains in functional capacity and muscle strength compared to no supervision. For the elderly with limited transport options to the hospital, home-based supervised programmes may be more convenient compared to hospital-based supervised programmes, but the former is costlier too. Home-interventions may also empower patients with the skills and confidence to maintain their physical fitness at home, which increases their likelihood of exercising after surgery.
The investigators propose a prospective single-center randomized controlled trial to evaluate the efficacy of preoperative prehabilitation with a home-based supervised exercise program (SEP) for frail elderly patients undergoing major abdominal surgery, compared to the mainstay of clinical practice, which is a home-based uSEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective major abdominal surgery
- •Lead time >= 14 days to surgery
- •Edmonton Frail Scale total score >= 6 points or Functional performance score (Timed up and Go(TUG)) >= 1 point
排除标准
- •Inability to provide written informed consent due to cognitive impairment
- •Having Comorbid medical conditions interfering with the ability to perform exercise at home or to complete the testing procedures. These include: i. Unstable cardiac conditions ii. Acute illnesses iii. Patients who are completely unable to walk
结局指标
主要结局
Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.
时间窗: From recruitment to 2-days before surgery
Distance that the patient can walk in 6 min, along a 15-20m hallway, at a pace that the participants will be tired at the end of the distance. This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
次要结局
- Hospital length-of-stay(From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first)
- Change in 6-minute walking distance(Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative)
- Maximal Inspiratory Pressure (MIP)(Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative)
- Handgrip strength (HGS)(Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative)
- 30-day in-hospital complications(From day of surgery to 30-days afterwards)
- Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L(Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative)
- Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12)(Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative)
- 30-second and 1-minute Sit-to-Stands (STS)(Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative)