PrehabilitationNCT06620588
PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
An observational study of Prehabilitation, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Prehabilitation
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Aug 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elective surgery patients , coming in for their pre-admission assessments
Who may be able to join
- Aged over 65 years who are undergoing elective major non-cardiac surgery
- Edmonton Frail Score (EFS) of 6 or higher
Who cannot join
- Patients who are unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Singapore, 68381
Hairil Rizal Abdullah, 63265428, hairil.rizal.abdullah@singhealth.com.sg
About this study
Official title: Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional
Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients with MIP<100 cmH2O. Currently, Singapore General Hospital offers the "Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE)" program, targeting frail patients undergoing major surgery. The primary outcome of the study is the change in physical function, measured by handgrip strength (HGS), from baseline to 3 days before surgery. Secondary outcomes include changes in the 6-minute walk test (6MWT), maximal inspiratory pressure (MIP), and sit-to-stand (STS) parameters from baseline to 3 days before surgery and 4-5 weeks postoperatively. Additionally, study will also assess postoperative complications (using the Comprehensive Complication Index), postoperative morbidity (using the Postoperative Morbidity Survey), length of hospital stay (LOS), and Health-Related Quality of Life (HRQoL) outcomes.
Read the detailed description
The exercise instructions given in the PREPARE program are part of the standard treatment and care is taken to ensure that the exercises are done safely at home. The only research segment is measurement of the parameters and clinical outcomes."
Patient Visits: 1. Recruitment/Enrollment (Visit 1 - coincide with PAC visit) Once informed consent is obtained. Patients will have the following measurements taken.
- Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer,
- 6-minute walk test (6MWT),
- handgrip strength (HGS) of the dominant hand, and
- 30s and 1-minute Sit-To-Stand (STS).
In addition, all patients will receive the routine (20 - 40 minutes) preoperative physiotherapy education, home exercise instructions and inspiratory muscle training (if MIP < 100 cmH2O).
- Follow up (Phone call) Patients will receive follow-up phone calls once weekly to check if they have any problems following the home exercise instructions given to them on visit 1.
- Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.
- Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.
- Conditions
- Prehabilitation
- Keywords
- Prehabilitation, frail, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PREPARE | Patients will receive the routine preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training if their maximal inspiratory pressure (MIP) is less than100 cmH2O. These sessions, lasting 20 to 40 minutes, will include physiotherapy education and instructions for a home-based, unsupervised exercise program. Additionally, patients will undergo study-related measurements of baseline MIP using a handheld digital manometer, the 6-minute walk test (6MWT), handgrip strength (HGS) of the dominant hand, and 30-second and 1-minute Sit-To-Stand (STS) tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength (HGS). HGS is a recognized marker of overall muscle and physical function and was chosen because it can be easily obtained from most frail elderly patients in our non-cardiac surgical population and is not limited by factors such as lower limb weakness, pain, or lower limb amputations.
Measured: Baseline
Secondary outcomes (6)
Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT
6MWT correlates moderately with anaerobic threshold and low preoperative 6MWT values have been associated with increased odds of developing postoperative pulmonary complications and poorer health-related quality of life in physical domains.
Measured: Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
Change in functional parameters : handgrip strength
Measured: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
30-day postoperative complications that will be assessed using the Comprehensive ComplicationIndex (CCI)
Measured: Up to 30 days after operation
Change in Health Related Quality of Life (HRQoL) outcomes, measured by the EQ-5D-3L, pre and post-operatively.
0-100 , 0 as the worse imaginable health state to the best imaginable health state
Measured: Baseline and pre-operation (4-5 weeks after op)
30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS)
Measured: Up to 30 days after operation
Change in functional parameters 30s and 1-min Sit to stand
Measured: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start5 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620588
- Sponsor's protocol ID
- PREPARE24
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional
- ClinicalTrials.gov ID
- NCT06620588
- Acronym / sponsor ID
- PREPARE24
- Conditions
- Prehabilitation
- Keywords
- Prehabilitation, frail, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 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.
Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients with MIP<100 cmH2O. Currently, Singapore General Hospital offers the "Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE)" program, targeting frail patients undergoing major surgery. The primary outcome of the study is the change in physical function, measured by handgrip strength (HGS), from baseline to 3 days before surgery. Secondary outcomes include changes in the 6-minute walk test (6MWT), maximal inspiratory pressure (MIP), and sit-to-stand (STS) parameters from baseline to 3 days before surgery and 4-5 weeks postoperatively. Additionally, study will also assess postoperative complications (using the Comprehensive Complication Index), postoperative morbidity (using the Postoperative Morbidity Survey), length of hospital stay (LOS), and Health-Related Quality of Life (HRQoL) outcomes.
Detailed description
The exercise instructions given in the PREPARE program are part of the standard treatment and care is taken to ensure that the exercises are done safely at home. The only research segment is measurement of the parameters and clinical outcomes."
Patient Visits: 1. Recruitment/Enrollment (Visit 1 - coincide with PAC visit) Once informed consent is obtained. Patients will have the following measurements taken.
- Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer,
- 6-minute walk test (6MWT),
- handgrip strength (HGS) of the dominant hand, and
- 30s and 1-minute Sit-To-Stand (STS).
In addition, all patients will receive the routine (20 - 40 minutes) preoperative physiotherapy education, home exercise instructions and inspiratory muscle training (if MIP < 100 cmH2O).
- Follow up (Phone call) Patients will receive follow-up phone calls once weekly to check if they have any problems following the home exercise instructions given to them on visit 1.
- Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.
- Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREPARE | – | –Patients will receive the routine preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training if their maximal inspiratory pressure (MIP) is less than100 cmH2O. These sessions, lasting 20 to 40 minutes, will include physiotherapy education and instructions for a home-based, unsupervised exercise program. Additionally, patients will undergo study-related measurements of baseline MIP using a handheld digital manometer, the 6-minute walk test (6MWT), handgrip strength (HGS) of the dominant hand, and 30-second and 1-minute Sit-To-Stand (STS) tests. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elective surgery patients , coming in for their pre-admission assessments
Key inclusion criteria (2 listed)
- Aged over 65 years who are undergoing elective major non-cardiac surgery
- Edmonton Frail Score (EFS) of 6 or higher
Key exclusion criteria (1 listed)
- Patients who are unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength
Time frame: Baseline
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength (HGS). HGS is a recognized marker of overall muscle and physical function and was chosen because it can be easily obtained from most frail elderly patients in our non-cardiac surgical population and is not limited by factors such as lower limb weakness, pain, or lower limb amputations.
6 secondary outcomes
Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT
Time frame: Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
Change in functional parameters : handgrip strength
Time frame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
30-day postoperative complications that will be assessed using the Comprehensive ComplicationIndex (CCI)
Time frame: Up to 30 days after operation
Change in Health Related Quality of Life (HRQoL) outcomes, measured by the EQ-5D-3L, pre and post-operatively.
Time frame: Baseline and pre-operation (4-5 weeks after op)
30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS)
Time frame: Up to 30 days after operation
Change in functional parameters 30s and 1-min Sit to stand
Time frame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prehabilitation, run by Singapore General Hospital at 1 site in Singapore.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hairil Rizal Abdullah (63265428, hairil.rizal.abdullah@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.