PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional

Last updated: September 26, 2024
Sponsor: Singapore General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06620588
PREPARE24
  • Ages 65-100
  • All Genders

Study 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

Inclusion Criteria:

  • Aged over 65 years who are undergoing elective major non-cardiac surgery

  • Edmonton Frail Score (EFS) of 6 or higher

Exclusion

Exclusion Criteria:

  • Patients who are unable to provide written informed consent

Study Design

Total Participants: 60
Study Start date:
August 05, 2024
Estimated Completion Date:
March 01, 2025

Study 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).

  1. 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.

  2. Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.

  3. Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.

Connect with a study center

  • Singapore General Hospital

    Singapore, 68381
    Singapore

    Active - Recruiting

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