Prehabilitation for Postoperative Complications

(STRIVE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Daniel McIsaac, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Cognitive impairment, Cardiac conditions, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Prehabilitation for Postoperative Complications is an effective treatment?

The available research shows that prehabilitation, which involves preparing patients before surgery, can lead to better outcomes after surgery. For example, it can improve how well patients function, reduce complications, and shorten hospital stays. Studies have found that prehabilitation is especially helpful for older patients who are more fragile. Compared to just doing rehabilitation after surgery, prehabilitation has been shown to be more effective in helping patients recover their physical abilities. This suggests that getting ready before surgery can make a big difference in how well patients do afterward. ^{1 2 3 4 5}

What safety data exists for prehabilitation in surgery?

The available research suggests that prehabilitation, including its variations like multidisciplinary prehabilitation and preoperative optimization, is generally safe and beneficial. Studies indicate that prehabilitation can reduce postoperative complications, improve functional status, and enhance quality of life. It is particularly effective in older adults with frailty and in patients undergoing colorectal cancer surgery. While more research is needed to fully understand its impact across different patient groups and conditions, current evidence supports its safety and efficacy in improving surgical outcomes. ^{3 6 7 8 9}

Is the treatment Prehabilitation a promising treatment for reducing postoperative complications?

Yes, Prehabilitation is a promising treatment because it helps improve patients' physical, nutritional, and mental health before surgery, which can lead to fewer complications after surgery, better recovery, and improved quality of life. ^{1 3 6 9 10}

Research Team

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

The STRIVE Before Surgery Trial is for individuals preparing for surgery who may have physical disabilities or are at risk of postoperative complications. Participants must be willing to engage in a home-based prehabilitation program and use an online platform.

Inclusion Criteria

My surgery is scheduled between 3 to 12 weeks after joining the trial.

Valid provincial health insurance number

Access to internet-enabled device

Exclusion Criteria

I cannot read or communicate in English.

I am not interested in participating based on my TAPA score.

I have had a heart, brain, or bone surgery.

Trial 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 including exercise, nutrition, and breathing techniques supported through an online platform

4-8 weeks

Virtual sessions 3 times per week

Surgery and Immediate Recovery

Participants undergo surgery and immediate postoperative recovery, including Inspiratory Muscle Training during early recovery

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness, including patient-reported disability and other health outcomes

1 month

1 in-person visit, virtual follow-ups

Long-term Follow-up

Participants' health-related quality of life and other outcomes are assessed at 3 months and 1 year post-surgery

1 year

Treatment Details

Interventions

• Prehabilitation (Behavioral Intervention)

Trial Overview This trial tests if a multimodal prehabilitation program can reduce patient-reported disability after surgery. Participants are randomly placed into two groups: one follows the prehabilitation regimen, while the other does not (control group).

Participant Groups

Group I: Prehabilitation Experimental Treatment 1 Intervention

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 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).

Prehabilitation is already approved in Canada for the following indications:

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ottawa Hospital Research Institute Ottawa, Canada

The Ottawa Hospital Ottawa, Canada

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Patients Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1417

Patients Recruited

26,550,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding value with prehabilitation in older persons receiving surgery. Ng, P., Lee, JKD., Tan, KY.[2023]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Prehabilitation for Lung Cancer Surgery: A Randomized Controlled Trial. Ferreira, V., Minnella, EM., Awasthi, R., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Bousquet-Dion, G., Awasthi, R., Loiselle, SÈ., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation for Preparing Older People with Frailty for Surgery]. Kiselev, J., Schaller, SJ., Schmidt, K., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in colorectal cancer surgery improves outcome and reduces hospital costs. Sabajo, CR., Ten Cate, DWG., Heijmans, MHM., et al.[2023]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review About Prehabilitation in Surgery: Current Situation and Future Perspectives. López Rodríguez-Arias, F., Sánchez-Guillén, L., Armañanzas Ruiz, LI., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in Frail Surgical Patients: A Systematic Review. Baimas-George, M., Watson, M., Elhage, S., et al.[2021]

References

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

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

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

Finding value with prehabilitation in older persons receiving surgery. [2023]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Multimodal Prehabilitation for Lung Cancer Surgery: A Randomized Controlled Trial. [2021]

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

Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Prehabilitation for Preparing Older People with Frailty for Surgery]. [2022]

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

Prehabilitation in colorectal cancer surgery improves outcome and reduces hospital costs. [2023]

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

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

9. Spain pubmed.ncbi.nlm.nih.gov

A Narrative Review About Prehabilitation in Surgery: Current Situation and Future Perspectives. [2021]

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

Prehabilitation in Frail Surgical Patients: A Systematic Review. [2021]