Prehabilitation for Surgery Preparation

Overseen By Emily Hladkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Cardiac, Neurological, Orthopedic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

144 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prehabilitation Intervention for surgery preparation?

Research shows that prehabilitation, which involves improving a patient's physical, nutritional, and mental health before surgery, can help them recover better after surgery. It has been effective in other types of surgeries, like orthopedic and heart surgeries, and is being increasingly used worldwide to improve surgical outcomes. ^{1 2 3 4 5}

Is prehabilitation safe for humans?

Prehabilitation has been evaluated for safety in humans, particularly before major surgeries, and has shown promising results in decreasing complications, suggesting it is generally safe. ^{2 6 7 8 9}

How does the prehabilitation treatment differ from other treatments for surgery preparation?

Prehabilitation is unique because it focuses on improving a patient's physical and mental health before surgery through a combination of exercises, nutrition, and education, which helps enhance recovery and reduce complications. Unlike other treatments that may only address issues post-surgery, prehabilitation aims to optimize the patient's condition beforehand, potentially leading to shorter hospital stays and better long-term health outcomes. ^{2 10 11 12 13}

What is the purpose of this trial?

The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with 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.

Research Team

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for adults over 18 who are scheduled for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery within the next 3 to 12 weeks. Participants must have a valid health insurance number and access to an internet-enabled device with an email address.

Inclusion Criteria

Valid provincial health insurance number

Access to internet-enabled device

Email address

Exclusion Criteria

No telephone/cell phone

I cannot read or communicate in English.

I am not interested in joining based on my physical activity phone assessment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a home-based multimodal prehabilitation program supported through an online platform, including exercise, nutrition, and breathing exercises

8-10 months

Virtual support through online platform

Surgery and Immediate Recovery

Participants undergo surgery and are monitored for immediate postoperative recovery and complications

Up to 1 month

In-hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after surgery

1 year

Follow-up assessments at 30 days, 3 months, and 1 year

Treatment Details

Interventions

• Prehabilitation Intervention

Trial Overview The STRIVE Trial is testing a home-based prehabilitation program delivered through an online platform before surgery. Participants are randomly placed into either the prehabilitation group or a control group to compare outcomes.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Prehabilitation, which involves preoperative interventions targeting physical, nutritional, and mental health, can significantly enhance postoperative outcomes by optimizing patients' conditions before surgery.

A multidisciplinary approach to prehabilitation creates a synergistic effect, leading to improved recovery, and although more high-quality evidence is needed, prehabilitation programs are being implemented globally, transforming perioperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation, making patients fit for surgery - a new frontier in perioperative care. Molenaar, CJL., Papen-Botterhuis, NE., Herrle, F., et al.[2021]

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

A systematic review of 17 studies, primarily focused on orthopedic surgeries, found that preoperative rehabilitation (prehabilitation) does not significantly improve functional status, quality of life, or pain after surgery.

However, prehabilitation may reduce the need for rehabilitation admissions following knee or hip arthroplasty for osteoarthritis, suggesting a potential benefit in this specific context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Prehabilitation on Postoperative Functional Status, Healthcare Utilization, Pain, and Quality of Life: A Systematic Review. Cabilan, CJ., Hines, S., Munday, J.[2018]

Prehabilitation aims to improve surgical outcomes by addressing modifiable risk factors before surgery, but understanding which interventions are effective for specific patients is crucial for its success.

Incorporating 'third-variable effects'—such as mediators, moderators, and confounders—into prehabilitation research design can help clarify how and when these interventions work, leading to better clinical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Third-Variable Effects: Tools to Understand Who, When, Why, and How Patients Benefit From Surgical Prehabilitation. Gillis, C., Gramlich, L., Culos-Reed, SN., et al.[2021]

This systematic review aims to evaluate the effectiveness of various prehabilitation interventions, such as physical activity and nutritional support, in improving surgical outcomes for patients undergoing elective surgery, based on randomized controlled trials (RCTs).

The review will follow rigorous guidelines and assess the quality of studies to identify which specific prehabilitation strategies are most effective in reducing postoperative complications and enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-admission interventions to improve outcome after elective surgery-protocol for a systematic review. Perry, R., Scott, LJ., Richards, A., et al.[2021]

A 4-week prehabilitation program involving physical therapy, nutritional support, and psychological preparation was safely implemented in 60 out of 106 patients scheduled for major abdominal surgery, with no cardiovascular events reported during the program.

Patients showed significant improvements in physical function (6-minute walking distance increased by 9.3%) and psychological well-being, suggesting that prehabilitation can enhance recovery and quality of life before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation before major abdominal surgery: Evaluation of the impact of a perioperative clinical pathway, a pilot study. Boukili, IE., Flaris, AN., Mercier, F., et al.[2022]

A systematic review of 33 studies involving 3167 citations found that prehabilitation did not significantly improve postoperative function, quality of life, or pain in patients undergoing knee or hip arthroplasty for osteoarthritis.

However, prehabilitation programs lasting over 500 minutes may reduce the need for postoperative rehabilitation, indicating a potential benefit in healthcare utilization, even though no significant reductions in readmissions or nursing home placements were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. Cabilan, CJ., Hines, S., Munday, J.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prehabilitation, making patients fit for surgery - a new frontier in perioperative care. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Prehabilitation before surgery: Is it for all patients? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Impact of Prehabilitation on Postoperative Functional Status, Healthcare Utilization, Pain, and Quality of Life: A Systematic Review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Third-Variable Effects: Tools to Understand Who, When, Why, and How Patients Benefit From Surgical Prehabilitation. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Pre-admission interventions to improve outcome after elective surgery-protocol for a systematic review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Statewide Prehabilitation Program and Episode Payment in Medicare Beneficiaries. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Prehabilitation before major abdominal surgery: Evaluation of the impact of a perioperative clinical pathway, a pilot study. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Prehabilitation for general surgery: a systematic review of randomized controlled trials. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Optimization of surgical outcomes with prehabilitation. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Prehabilitation: the anesthesiologist's role and what is the evidence? [2021]