Clinical trial NCT04892368: Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Frailty
Surgery
Keywords: prehabilitation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.
timeFrame: From recruitment to 2-days before surgery
Secondary outcomes:
measure: 30-day in-hospital complications
timeFrame: From day of surgery to 30-days afterwards
measure: Hospital length-of-stay
timeFrame: From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
measure: Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12)
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
measure: Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
measure: Change in 6-minute walking distance
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
measure: 30-second and 1-minute Sit-to-Stands (STS)
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
measure: Handgrip strength (HGS)
timeFrame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Eileen Yilin Sim
Study officials:
References: