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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSingapore General Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
baseline to 1-3 days pre-surgery.

Secondary outcomes

1

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

Time frame
Baseline to 1-3 days before the surgery
2

Postoperative complications

Postoperative complications will be categorised according to the ACS NSQIP postoperative complications criteria.

Time frame
Preoperative to up to 4 weeks after surgery.
3

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.

Time frame
Preoperative to up to 8 weeks after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: