NCT06620588 PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
| NCT ID | NCT06620588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore General Hospital |
| Condition | Prehabilitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-08-05 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06620588 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 100 Years, studying Prehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06620588 currently recruiting?
Yes, NCT06620588 is actively recruiting participants. Contact the research team at hairil.rizal.abdullah@singhealth.com.sg for enrollment information.
Where is the NCT06620588 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06620588 clinical trial?
NCT06620588 is sponsored by Singapore General Hospital. The trial plans to enroll 60 participants.