PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional

NCT06620588 | Recruiting

• 1 other identifier: PREPARE24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation

Keywords

Prehabilitation; frail; elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elective surgery patients , coming in for their pre-admission assessments

You may qualify if:

• Aged over 65 years who are undergoing elective major non-cardiac surgery
• Edmonton Frail Score (EFS) of 6 or higher

You may not qualify if:

• Patients who are unable to provide written informed consent

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 68381, Singapore

RECRUITING

Central Study Contacts

Hairil Rizal Abdullah

CONTACT

63265428; hairil.rizal.abdullah@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: October 1, 2024
• Study Start: August 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-08

Locations

SG (1)