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)

May 30, 2021 updated by: Singapore General Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Eileen Yilin Sim
        • Contact:
        • Sub-Investigator:
          • Hairil Rizal Abdullah, MBBS
        • Principal Investigator:
          • Eileen Sim, MBBS
        • Sub-Investigator:
          • Chun Ju Tan, Msc
        • Sub-Investigator:
          • Kwong Wei Emile John Tan, MBBS
        • Sub-Investigator:
          • Meihuan Chang, MBBS
        • Sub-Investigator:
          • Jia Lin Ng, MBBS
        • Sub-Investigator:
          • Ee-Lin Toh, MBBS
        • Sub-Investigator:
          • Chung Yip Chang, MBBS
        • Sub-Investigator:
          • Hwee Kuan Ong, DClinPT
        • Sub-Investigator:
          • Eleanor Shuxian Chew, Msc
        • Sub-Investigator:
          • Thiri Naing Thin, BN
        • Sub-Investigator:
          • Pei Yi Brenda Tan, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: Home-based supervised exercise program
Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.
NO_INTERVENTION: Home unsupervised exercise program
This group receives standard preoperative physiotherapy education as well a home-exercise instructions.

What is the study measuring?

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.
Time Frame: From recruitment to 2-days before surgery
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
Time Frame: From day of surgery to 30-days afterwards
Classified using the Clavien Dindo Classification
From day of surgery to 30-days afterwards
Hospital length-of-stay
Time Frame: From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
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)
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
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
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
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
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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)
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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)
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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)
Time Frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2021

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (ACTUAL)

May 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-PREPARE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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