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

NCT06633614 | Not Yet Recruiting DMC

• 1 other identifier: 202410-01
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frailty Syndrome

Keywords

Prehabilitation; Home-based; Perioperative Science; Wearable Technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional assessments

  Baseline to 1-3 days before the surgery

• Postoperative complications

  Preoperative to up to 4 weeks after surgery.

• Health Services outcomes

  Preoperative to up to 8 weeks after surgery.

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Supervised prehabilitation programme DEVICE

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.

Also known as: swSEP

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead

Related Publications (1)

• Leong YH, Tay VYJ, Yang X, Tan CJ, Au-Yong PS, Sim JLX, Ng RRG, Ong MEH, Tan BPY, Abdullah HR, Ke Y. Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care. BMJ Open. 2025 Oct 23;15(10):e094986. doi: 10.1136/bmjopen-2024-094986.

  PMID: 41130682 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuhe Ke, MMED (ANES)

CONTACT

+65 6321 4220; ke.yuhe@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding The investigators will not be blinded, as they will be responsible for prescribing the intervention bundle to participants in the intervention arm. However, hospital staff, including nurses and surgeons, will be blinded to the allocation of study arms. It is acknowledged that maintaining full blinding for the treating team in the postoperative period may be challenging, as study details could potentially be disclosed by participants who are not blinded. Efforts will be made to minimise such disclosures to preserve blinding where possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: This randomized controlled trial (RCT) will compare a prehabilitation program using wearable technology (swSEP) with standard preoperative care (uSEP) in elderly patients undergoing major abdominal surgery. Participants will be randomly assigned to either the intervention or control group, with stratification based on baseline physical function, surgical risk, and physiotherapist involvement. The intervention group will follow a personalized exercise program, remotely supervised via telemedicine, and monitored through a Fitbit Aspire 3 device. The control group will receive standard care without wearable technology. The trial will assess improvements in physical function, postoperative outcomes, and recovery at 4 weeks, aiming to determine the superiority of the prehabilitation program over standard care.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 9, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share