Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Frailty, Surgery, Frail Elderly Syndrome

Intervention / Treatment
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* Other: Home-based supervised exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Elective major abdominal surgery 2. Lead time >= 14 days to surgery 3. Edmonton Frail Scale total score >= 6 points or Functional performance score (Timed up and Go(TUG)) >= 1 point Exclusion Criteria: 1. Inability to provide written informed consent due to cognitive impairment 2. 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home supervised exercise program<br>This group receives standard preoperative physiotherapy education as well a home-exercise instructions. They will also receive 3-4 home visits by physiotherapists between recruitment and surgery, to conduct exercises in their homes. | Other: Home-based supervised exercise program<br>* Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.<br>|
| No Intervention: Home unsupervised exercise program<br>This group receives standard preoperative physiotherapy education as well a home-exercise instructions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance. | 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. | From recruitment to 2-days before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day in-hospital complications | Classified using the Clavien Dindo Classification | From day of surgery to 30-days afterwards | 
| Hospital length-of-stay | Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care | From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first | 
| Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12) | SF-12 is a 12-item questionnaire that assesses generic health outcomes from the patient's perspective, and covers eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional & mental health. | 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 EQ-5D-3L | The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. | Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative | 
| Change in 6-minute walking distance | 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. | Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative | 
| Maximal Inspiratory Pressure (MIP) | The maximal inspiratory pressure reflects the strength of inspiratory muscles. | Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative | 
| 30-second and 1-minute Sit-to-Stands (STS) | The Sit to Stand test reflects lower-extremity strength and endurance. | Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative | 
| Handgrip strength (HGS) | The handgrip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It reflects upper body strength and overall strength. | Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation