Clinical trial NCT06620588: PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
Official title: Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery: a Pilot Interventional
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prehabilitation
Keywords: Prehabilitation
frail
elderly
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elective surgery patients , coming in for their pre-admission assessments

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.

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

Primary outcomes:
measure: The change in physical function between baseline and 3 days prior to surgery as measured by the handgrip strength
timeFrame: Baseline
Secondary outcomes:
measure: Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT
timeFrame: Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
measure: Change in functional parameters : handgrip strength
timeFrame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
measure: 30-day postoperative complications that will be assessed using the Comprehensive ComplicationIndex (CCI)
timeFrame: Up to 30 days after operation
measure: Change in Health Related Quality of Life (HRQoL) outcomes, measured by the EQ-5D-3L, pre and post-operatively.
timeFrame: Baseline and pre-operation (4-5 weeks after op)
measure: 30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS)
timeFrame: Up to 30 days after operation
measure: Change in functional parameters 30s and 1-min Sit to stand
timeFrame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: