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NCT Number: NCT06620588

PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional

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.

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Key information

Conditions

Prehabilitation

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore General Hospital

Singapore, 68381

Location status: Recruiting

Location contact

Hairil Rizal Abdullah

CONTACT

[email protected]

63265428

About this study

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.

  • Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer,
  • 6-minute walk test (6MWT),
  • handgrip strength (HGS) of the dominant hand, and
  • 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).

  • 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.
  • Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.
  • Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in 6-minute walk test (6MWT) from baseline to day of surgery to postoperatively 6MWT

    Time frame: Baseline, 3 days prior to surgery and between 4-5 weeks postoperatively

    6MWT correlates moderately with anaerobic threshold and low preoperative 6MWT values have been associated with increased odds of developing postoperative pulmonary complications and poorer health-related quality of life in physical domains.

  2. Change in functional parameters : handgrip strength

    Time frame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively

  3. 30-day postoperative complications that will be assessed using the Comprehensive ComplicationIndex (CCI)

    Time frame: Up to 30 days after operation

  4. Change in Health Related Quality of Life (HRQoL) outcomes, measured by the EQ-5D-3L, pre and post-operatively.

    Time frame: Baseline and pre-operation (4-5 weeks after op)

    0-100 , 0 as the worse imaginable health state to the best imaginable health state

  5. 30-day postoperative complications that will be assessed using the Postoperative Morbidity Survey (POMS)

    Time frame: Up to 30 days after operation

  6. Change in functional parameters 30s and 1-min Sit to stand

    Time frame: baseline, 3 days prior to surgery and between 4-5 weeks postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Hairil Rizal Abdullah

CONTACT

[email protected]

63265428

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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