PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prehabilitation. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional
Overview
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.
1. Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer, 2. 6-minute walk test (6MWT), 3. handgrip strength (HGS) of the dominant hand, and 4. 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).
2\. 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.
3\. Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.
4\. Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.
Primary outcome measures
- The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength [Time frame: Baseline]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- Aged over 65 years who are undergoing elective major non-cardiac surgery
- Edmonton Frail Score (EFS) of 6 or higher
Exclusion criteria
- Patients who are unable to provide written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Singapore · 1 center
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT06620588 · PREPARE24