Frailty SyndromePREPARE@HOMENCT06633614
PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables
A study testing Supervised prehabilitation programme in people with Frailty Syndrome, run by Singapore General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Supervised prehabilitation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Frailty Syndrome
- Being tested
- Supervised prehabilitation programme
- Keywords
- Prehabilitation, Home-based, Perioperative Science, Wearable Technology
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised prehabilitation programmeDevice
Also called swSEP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Supervised prehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline to 1-3 days pre-surgery.
Secondary outcomes (3)
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
Measured: Baseline to 1-3 days before the surgery
Postoperative complications
Postoperative complications will be categorised according to the ACS NSQIP postoperative complications criteria.
Measured: 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.
Measured: Preoperative to up to 8 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Aug 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke Yuhe, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633614
- Sponsor's protocol ID
- 202410-01
- Acronym
- PREPARE@HOME
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant data will be identifiable in this study, and is not passed by the ethics board to share the data.
Publications
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.
PubMed 41130682
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06633614
- Acronym / sponsor ID
- PREPARE@HOME / 202410-01
- Conditions
- Frailty Syndrome
- Keywords
- Prehabilitation, Home-based, Perioperative Science, Wearable Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Supervised prehabilitation programmeParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised prehabilitation programmeAlso: swSEPParticipants 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. | Device | Intervention |
Primary outcome
Change in Physical Function (6-Minute Walk Test) from baseline to before surgery.
Time frame: baseline to 1-3 days pre-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).
3 secondary outcomes
Functional assessments
Time frame: Baseline to 1-3 days before the surgery
Postoperative complications
Time frame: Preoperative to up to 4 weeks after surgery.
Health Services outcomes
Time frame: Preoperative to up to 8 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41130682Leong 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.
- Individual participant dataSharing planned: No. The participant data will be identifiable in this study, and is not passed by the ethics board to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised prehabilitation programme in people with Frailty Syndrome, run by Singapore General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuhe Ke, MMED (ANES) (+65 6321 4220 ext. +65, ke.yuhe@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (6-Minute Walk Test) from baseline to before surgery. (time frame: baseline to 1-3 days pre-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.