Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-10 @ 6:42 PM
Study NCT ID:
NCT06511258
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The STRIVE Before Surgery Trial
Sponsor:
Ottawa Hospital Research Institute
Organization:
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:
False
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 1.4 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 0.3. 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 0.3. 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:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: