Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511258
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
The STRIVE Before Surgery Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The STRIVE Before Surgery Pilot Trial a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment STRIVE Before Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
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:
STRIVE
Brief Summary:
The STRIVE Before Surgery Trial evaluates patient-reported disability at 30 days after surgery following participating in a home-based multimodal prehabilitation program supported through an online platform Half of the participants will be randomized into the prehabilitation group while the other half will be randomized into the control group
Detailed Description:
Background The number of people presenting for surgery and their risk profile are increasing People presenting for surgery face substantial risk of postoperative adverse events Fifteen to 30 of patients suffer a serious medical or surgical complication after surgery and 1 in 5 develop a new patient-reported disability that reflects a loss of independence in day-to-day life More than 14 million inpatient surgical procedures are performed in Canada each year Globally 300 million surgical procedures occur annually As an increasing number of people present for surgery the average risk profile of this population is rising Surgical patients are typically older and live with comorbidity This means that strategies to improve patient outcomes and reduce resource utilization are urgently needed Patients the public clinicians and policy makers participating in 2 separate James Lind Alliance Priority Setting Partnerships Canada UK identified prehabilitation as a Top 10 priority for perioperative research Furthermore prehabilitation is currently discussed in the popular media as a strategy to improve outcomes for the growing number of high-risk patients presenting for surgery
Overarching Aim The pilot phase evaluated three pragmatic elements recruitment adherence and follow-up that our experience in prehabilitation research demonstrate are necessary to support successful large-scale evaluation Data from the pilot phase will be combined with this full-scale trial The full-scale trial will evaluate patient reported disability at 30 days after surgery
Methods
Design setting and participants The STRIVE Before Surgery Trial is an assessor blinded multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial
People 18 years old having inpatient abdominal thoracic pelvic head-and-neck or vascular surgery with expected length of stay of 2 days will be included
Intervention The intervention includes 3 aspects exercise nutrition and breathing Our intervention is a home-based multimodal prehabilitation program supported through an online platform
Outcomes and sample size Primary outcome is patient-reported disability 30 days after surgery Secondary outcomes are days at home in the 30 days after surgery survival health-related quality of life length of stay patient safety indicators intensive care unit admission non-home discharge readmission emergency department visits health system costs and elicitation of patient clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework Our trial sample size calculation is informed by parameter estimates from the pilot phase A sample of 902 patients 451 per arm will provide 90 power to detect a 5 minimally important difference between the mean WHODAS scores using an F-test from an Analysis of Covariance ANCOVA at the two-sided 5 significance level We conservatively assumed a common standard deviation of 23 equal to the upper limit of the 95 CI observed in our vanguard trial and a correlation with baseline of 03 We also allowed for up to 10 attrition
Expertise The team features multidisciplinary clinical and methodological experts nationally representative knowledge users and patient representatives
Expected outcomes Despite systematic review findings that exercise prehabilitation may improve physical performance and function limitations exist that preclude generalizability including many identified studies being high or unclear risk of bias and single center studies with 100 participants The investigators aim to conduct this low risk of bias mutli-center study of adult surgical patients 18 years to address this gap
Overarching Aim The pilot phase evaluated three pragmatic elements recruitment adherence and follow-up that our experience in prehabilitation research demonstrate are necessary to support successful large-scale evaluation Data from the pilot phase will be combined with this full-scale trial The full-scale trial will evaluate patient reported disability at 30 days after surgery
Methods
Design setting and participants The STRIVE Before Surgery Trial is an assessor blinded multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial
People 18 years old having inpatient abdominal thoracic pelvic head-and-neck or vascular surgery with expected length of stay of 2 days will be included
Intervention The intervention includes 3 aspects exercise nutrition and breathing Our intervention is a home-based multimodal prehabilitation program supported through an online platform
Outcomes and sample size Primary outcome is patient-reported disability 30 days after surgery Secondary outcomes are days at home in the 30 days after surgery survival health-related quality of life length of stay patient safety indicators intensive care unit admission non-home discharge readmission emergency department visits health system costs and elicitation of patient clinician and researcher-identified barriers to our pragmatic trial using the Theoretical Domains Framework Our trial sample size calculation is informed by parameter estimates from the pilot phase A sample of 902 patients 451 per arm will provide 90 power to detect a 5 minimally important difference between the mean WHODAS scores using an F-test from an Analysis of Covariance ANCOVA at the two-sided 5 significance level We conservatively assumed a common standard deviation of 23 equal to the upper limit of the 95 CI observed in our vanguard trial and a correlation with baseline of 03 We also allowed for up to 10 attrition
Expertise The team features multidisciplinary clinical and methodological experts nationally representative knowledge users and patient representatives
Expected outcomes Despite systematic review findings that exercise prehabilitation may improve physical performance and function limitations exist that preclude generalizability including many identified studies being high or unclear risk of bias and single center studies with 100 participants The investigators aim to conduct this low risk of bias mutli-center study of adult surgical patients 18 years to address this gap
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