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Clinical Trials/NCT06620588
NCT06620588
Recruiting
N/A

Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional

Singapore General Hospital1 site in 1 country60 target enrollmentAugust 5, 2024
ConditionsPrehabilitation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prehabilitation
Sponsor
Singapore General Hospital
Enrollment
60
Locations
1
Primary Endpoint
The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT(Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively)
  • Change in functional parameters : handgrip strength(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)(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.(Baseline and pre-operation (4-5 weeks after op))
  • 30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS)(Up to 30 days after operation)
  • Change in functional parameters 30s and 1-min Sit to stand(baseline, 3 days prior to surgery and between 4-5 weeks postoperatively)

Study Sites (1)

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