Prehabilitation for Postoperative Complications

(STRIVE Trial)

Recruiting at 1 trial location

Overseen By Emily Hladkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Cognitive impairment, Cardiac conditions, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

902 Participants Needed

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.

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

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 European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

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]

Multimodal prehabilitation programs that include exercise, nutrition, and psychological support have been shown to improve functional outcomes and reduce complications for older and frail patients undergoing surgery, based on systematic reviews and meta-analyses.

Targeting prehabilitation efforts towards high-risk patients and individualizing programs can enhance adherence and effectiveness, ultimately leading to better postoperative recovery and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

A multimodal prehabilitation program starting 4 weeks before lung cancer surgery did not show any significant advantage over rehabilitation starting 8 weeks after surgery in terms of functional recovery, as measured by the 6-minute walk test.

Both prehabilitation and rehabilitation groups achieved similar functional capacity recovery by 8 weeks post-operation, with over 75% of patients returning to their baseline functional levels.

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]

Adding a weekly supervised exercise session to a prehabilitation program did not significantly improve postoperative walking capacity compared to standard rehabilitation in patients undergoing colorectal cancer surgery.

However, previously inactive patients showed a greater likelihood of improving their functional capacity with the enhanced prehabilitation program, indicating that tailored approaches may benefit specific patient groups.

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]

Frailty in older adults increases the risk of complications during and after surgery, but this condition can be improved through targeted therapeutic and medical interventions.

Prehabilitation, which includes these interventions, has been shown to reduce surgical complications, enhance rehabilitation, improve quality of life, and help maintain independence in older patients.

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]

Patients undergoing elective colorectal surgery who participated in a multimodal prehabilitation program experienced significantly lower overall complication rates (31% vs 40%) and severe complication rates (20% vs 31%) compared to those receiving standard care.

The prehabilitation group also had a shorter average hospital stay (5.80 days vs 6.71 days) and resulted in cost savings of €1109 per patient, despite an initial investment of €969 for the prehabilitation program.

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]

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]

Prehabilitation programs, which focus on improving physical condition, nutrition, and cognitive health, aim to reduce postoperative complications by optimizing patients from diagnosis to surgery.

These programs have synergistic effects, where small individual improvements combine to significantly enhance postoperative recovery, highlighting the need for their integration into routine clinical practice despite the need for more research on their impact across various patient groups.

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]

Prehabilitation, which includes exercise, nutrition, and psychosocial counseling, may improve postoperative outcomes for frail surgical patients, as suggested by a review of five studies.

Despite the potential benefits of prehabilitation in reducing surgical risks, there is currently limited evidence supporting its widespread use, highlighting the need for more randomized controlled trials in this area.

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]