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

NCT ID: NCT04892368

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Frail Elderly Syndrome Frailty Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home supervised exercise program

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.

Group Type ACTIVE_COMPARATOR

Home-based supervised exercise program

Intervention Type OTHER

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

Home unsupervised exercise program

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based supervised exercise program

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

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eileen Yilin Sim

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Eileen Y Sim

Role: CONTACT

Facility Contacts

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Eileen Y Sim

Role: primary

Other Identifiers

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H-PREPARE-01

Identifier Type: -

Identifier Source: org_study_id

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