PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Prehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT06620588

PREPARE24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

PREPARE

Description:

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.