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

S

Singapore Health Services (SingHealth)

Status

Unknown

Conditions

Surgery
Frailty
Frail Elderly Syndrome

Treatments

Other: Home-based supervised exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT04892368
H-PREPARE-01

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Elective major abdominal surgery
    1. Lead time >= 14 days to surgery
    1. 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
    1. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Home supervised exercise program
Active Comparator group
Description:
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.
Treatment:
Other: Home-based supervised exercise program
Home unsupervised exercise program
No Intervention group
Description:
This group receives standard preoperative physiotherapy education as well a home-exercise instructions.

Trial contacts and locations

1

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Central trial contact

Eileen Y Sim

Data sourced from clinicaltrials.gov

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