Prehabilitation program before surgery to reduce complications
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
This study is testing if a home-based program to help people get stronger before surgery can reduce complications and improve recovery for patients facing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 902 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06511258 on ClinicalTrials.gov |
What this trial studies
The STRIVE Before Surgery Trial evaluates the effectiveness of a home-based multimodal prehabilitation program delivered through an online platform. Participants will be randomly assigned to either the prehabilitation group or a control group, with the aim of assessing patient-reported disability 30 days post-surgery. This approach addresses the increasing risk of postoperative complications among surgical patients, particularly those with comorbidities. The trial seeks to gather data on recruitment, adherence, and follow-up to support future large-scale evaluations of prehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for inpatient abdominal, thoracic, pelvic, head-and-neck, or vascular surgery within 3 to 12 weeks of enrollment.
Not a fit: Patients undergoing cardiac, neurological, or orthopedic procedures, or those requiring palliative surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce postoperative complications and improve recovery outcomes for surgical patients.
How similar studies have performed: Previous studies have indicated that prehabilitation can improve surgical outcomes, making this approach promising and supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel McIsaac, MD,MPH,FRCPC — The Ottawa Hospital
- Study coordinator: Emily Hladkowicz, PhD
- Email: emhladkowicz@toh.ca
- Phone: 613-798-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.