Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620588
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
PREPARE-M 2024 Undergoing Major Surgery a Pilot Interventional
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Outcomes of a Prehabilitation Programme for Surgical Patients Undergoing Major Surgery a Pilot Interventional
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MIP100 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 RecruitmentEnrollment 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
Patient Visits 1 RecruitmentEnrollment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None