PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables (PREPARE@HOME)

PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether a prehabilitation program using wearable technology can improve physical function and postoperative outcomes in elderly patients (65 years or older) undergoing major elective non-cardiac surgery. The main questions it aims to answer are:

Does the prehabilitation program improve physical function, as measured by the 6-minute walk test (6MWT), from baseline to pre-surgery? Does the prehabilitation program reduce postoperative complications and enhance recovery? Researchers will compare participants who receive the prehabilitation program with wearable technology (intervention group) to those receiving standard preoperative care (control group) to see if the intervention results in greater improvements in physical function and postoperative outcomes.

Participants will:

Follow a personalized exercise program monitored remotely via telemedicine. Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity.

Undergo assessments of physical function and quality of life before surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty Syndrome
• Intervention / Treatment: Device: Supervised prehabilitation programme

Detailed Description

This clinical trial aims to investigate the effectiveness of a prehabilitation program using wearable technology to improve physical function and postoperative outcomes in elderly patients undergoing major elective non-cardiac surgery. The intervention group will receive a comprehensive preoperative rehabilitation program (swSEP) that includes personalized exercise regimens monitored via telemedicine and a wearable device (Fitbit Aspire 3) to track key physiological metrics such as heart rate, physical activity, and sleep patterns. The exercise program will consist of three components: strength training, aerobic exercises, and flexibility exercises. These sessions will be conducted three times per week, with adjustments made by the physiotherapist based on the participant's progress and vital sign responses.

Participants will be monitored closely through telemedicine check-ins twice per week to ensure adherence to the exercise program, address any challenges, and make modifications to the regimen as needed. In addition, all participants will undergo baseline functional assessments, including the 6-minute walk test (6MWT), 30-second sit-to-stand test (30sSTS), handgrip strength (HGS), and maximal inspiratory pressure (MIP), as well as nutritional and quality of life assessments using the MUST score and EQ-5D-5L questionnaire. These assessments will be repeated 1-3 days before surgery to evaluate any improvements in physical function.

The control group (uSEP) will receive standard preoperative care, which includes physiotherapy education and a home-based exercise booklet, but will not be provided with a wearable device or telemedicine supervision. Both groups will be monitored for postoperative outcomes, including the incidence of complications classified by the Clavien-Dindo system, hospital length of stay, ICU admissions, and hospital readmissions. Health-related quality of life (HRQoL) will also be measured at multiple time points.

Exploratory analyses will include postoperative recovery and resumption of physical activity at 12 weeks post-surgery, as well as heart rate variability (HRV) data from the wearable devices to assess physiological responsiveness to the prehabilitation program and its potential predictive value for postoperative outcomes. A qualitative interview study will be conducted concurrently to explore the barriers and facilitators of home-based prehabilitation from the perspectives of both patients and healthcare providers.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuhe Ke, MMED (ANES); Phone Number: +65 +65 6321 4220; Email: ke.yuhe@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Frail elderly patients aged 65 years or older.
• Scheduled to undergo major elective, non-cardiac surgery.
• Anticipated surgery duration of over two hours or expected blood loss greater than 500 mL.
• Frailty status with Edmonton Frail Scale (EFS) score of 6 or higher.
• Capacity to provide informed consent independently.
• Available at least two weeks before surgery to participate in the prehabilitation program.
• Ability to follow exercise instructions independently.
• Ownership of a smartphone with Bluetooth and cellular connectivity.

Exclusion Criteria:

• Severe comorbidities that interfere with participation in the exercise program (e.g., unstable angina, severe aortic stenosis, or uncontrolled arrhythmias).
• Cognitive impairments that prevent understanding or adherence to the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in the control group (uSEP) will receive the standard PREPARE program provided by the hospital, which includes preoperative physiotherapy education and a home exercise booklet (Supplementary Material: Educational Materials). This unsupervised, home-based programme consists of full-body aerobic, resistance, and respiratory exercises that participants will perform independently at home. Additionally, participants with a Maximal Inspiratory Pressure (MIP) of less than 100 cmH₂O will be given an Inspiratory Muscle Trainer (IMT) to enhance respiratory function.
Experimental: Intervention; Participants in the intervention group (swSEP) will receive standard preoperative physiotherapy education in addition to a Fitbit Aspire 3 wearable device, which will track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalised exercise program that is remotely supervised by a physiotherapist via telemedicine twice a week. The exercise regimen will consist of 20-minute sessions, at least three times per week, and will include three core components: strength training, aerobic exercise, and flexibility exercises. Strength training will involve 2-3 sets of full-body exercises, including combinations of upper body, lower body, and abdominal movements. Aerobic exercises will be performed at a minimum intensity of 40% of the participant's maximal heart rate (HRmax) for up to 20 minutes. Flexibility training will include six stretches, each held for 20 seconds and repeated twice, targeting the chest, arms, legs, and trunk.	Device: Supervised prehabilitation programme; Participants will receive standard preoperative physiotherapy education along with a Fitbit Aspire 3 wearable device to track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalized exercise program, supervised remotely by a physiotherapist via telemedicine twice a week. The program will include 20-minute sessions at least three times per week, focusing on strength training, aerobic exercises (at 40% of maximal heart rate), and flexibility exercises. Progress will be monitored through vital signs and workout data, with the physiotherapists adjusting the regimen as needed. Participants with low inspiratory pressure (MIP <100 cmH₂O) will receive an Inspiratory Muscle Trainer (IMT). Additionally, some participants may be provided with a portable cycle pedometer featuring adjustable resistance. To ensure safety, both participants and caregivers will receive a safety briefing, and a 24-hour emergency hotline.; Other Names: swSEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function (6-Minute Walk Test) from baseline to before surgery.	The primary outcome of this study will be the change in physical function from baseline to 1 to 3 pre-surgery, measured by the 6-minute walk test (6MWT).	baseline to 1-3 days pre-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional assessments	Functional outcomes will encompass the 30-second sit-to-stand test (30sSTS) and handgrip strength (HGS) will be measured from baseline to 1-3 days before the surgery	Baseline to 1-3 days before the surgery
Postoperative complications	Postoperative complications will be categorised according to the ACS NSQIP postoperative complications criteria.	Preoperative to up to 4 weeks after surgery.
Health Services outcomes	Health services outcomes, including hospital length of stay, intensive care unit (ICU) admissions, hospital readmissions, and associated healthcare costs, will also be recorded to assess the intervention's impact on healthcare resource utilisation. Health-related quality of life (HRQoL) will be evaluated using the EQ-5D-5L questionnaires before and 8 weeks after surgery.	Preoperative to up to 8 weeks after surgery.

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Prehabilitation; Home-based; Wearable Technology; Perioperative Science
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 202410-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participant data will be identifiable in this study, and is not passed by the ethics board to share the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No