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

NCT04892368 | Unknown

• 1 other identifier: H-PREPARE-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome; Frailty; Surgery

Keywords

prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 30-day in-hospital complications

  From day of surgery to 30-days afterwards

• Hospital length-of-stay

  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)

  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

  Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative

• Change in 6-minute walking distance

  Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative

Study Arms (2)

Home supervised exercise program

ACTIVE COMPARATOR

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

Home unsupervised exercise program

NO INTERVENTION

This group receives standard preoperative physiotherapy education as well a home-exercise instructions.

Interventions

Home-based supervised exercise program OTHER

Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.

Home supervised exercise program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Eileen Yilin Sim

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eileen Y Sim

CONTACT

93804422; eileen.sim.y.l@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 19, 2021
• Study Start: April 10, 2021
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)