The STRIVE Before Surgery Trial

NCT ID: NCT06511258

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2031-12-01

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.

Conditions

Surgery-Complications; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prehabilitation

The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions \>= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: BEHAVIORAL

The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Control

To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and \>65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prehabilitation

The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery

3. Expected surgery date between 3 and 12 weeks from enrollment

4. Valid provincial health insurance number

5. Access to internet-enabled device

6. Email address

Exclusion Criteria

1. Inability to read and communicate in English

2. Cognitive impairment preventing ability to provide informed consent independently

3. No telephone/cell phone

4. Cardiac, neurological or orthopedic procedure

5. Surgery with no curative intent (palliative surgery)

6. Patient not interested in participating in the context of their TAPA score

7. Any of the following cardiovascular conditions:

1. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea

2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea

3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel McIsaac, MD,MPH,FRCPC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Emily Hladkowicz, PhD

Role: CONTACT

emhladkowicz@toh.ca

613-798-5555 ext. 18629

Facility Contacts

Emily Hladkowicz, PhD

Role: primary

emhladkowicz@toh.ca

613-798-5555 ext. 18629

Other Identifiers

OHSN-REB 20230399-01T

Identifier Type: -

Identifier Source: org_study_id