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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based program called Prehabilitation, designed to enhance recovery after surgery. Participants will engage in exercises, nutritional support, and breathing techniques, all accessed through an online platform. The aim is to determine if these activities can reduce disability 30 days post-surgery. Individuals planning to undergo certain surgeries, such as abdominal or head-and-neck surgery, and who have internet access, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative recovery strategies and potentially improve surgical outcomes for future patients.

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 prior data suggests that this prehabilitation program is safe?

Research has shown that prehabilitation, which includes exercises, nutrition, and breathing techniques, is generally safe for people preparing for surgery. Studies have found that these programs can reduce complications during and after surgery, shorten hospital stays, and improve recovery.

Regarding safety, one study examined a prehabilitation program for frail patients and found it practical and safe. This indicates the program is well-tolerated, even by those at higher risk.

Overall, evidence suggests that prehabilitation is a safe option for those preparing for surgery, improving outcomes without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prehabilitation approach because it proactively prepares patients for surgery, potentially reducing postoperative complications. Unlike standard care, which typically focuses on recovery after surgery, this method emphasizes a combination of exercise, nutritional support, and breathing techniques to boost patients' strength and resilience before the procedure. By engaging patients in strength training, cardio, and stretching, along with providing protein supplements and breathing exercises, this comprehensive strategy aims to improve surgical outcomes and speed up recovery. This innovative approach could transform how we support patients undergoing surgery, making the recovery process smoother and more efficient.

What evidence suggests that prehabilitation is effective for reducing postoperative complications?

Research has shown that prehabilitation—exercises, nutrition, and breathing training before surgery—can halve the risk of complications. In this trial, participants in the prehabilitation arm will engage in these activities, which studies have found can also reduce hospital stays by more than a day. Patients who participated in prehabilitation experienced fewer post-surgery issues, such as breathing problems and other complications. Overall, this approach improves physical health before surgery, leading to a smoother and faster recovery. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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

Valid provincial health insurance number

Access to internet-enabled device

Email address

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144543/

Prehabilitation: Impact on Postoperative Outcomes - PMC Prehabilitation enhances physiological reserve and thereby potentially reduces the incidence of postoperative complications. Studies have shown ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324007601

Review Article Real-life effectiveness of prehabilitation to ... Pooled results of the observational studies showed that the odds for postoperative complications were ∼50 % lower, and LoS was 1.34 days shorter in the ...

3. nature.com nature.com/articles/s41598-024-66633-6

Multimodal prehabilitation and postoperative outcomes in ... Five studies described PPCs, and participants with prehabilitation had decreased odds of PPC (− 0.96 [− 1.38– − 0.54], P < 0.001).

4. cureus.com cureus.com/articles/415000-the-effects-of-multimodal-prehabilitation-on-postoperative-outcomes-in-colorectal-surgery-a-systematic-review-and-meta-analysis

The Effects of Multimodal Prehabilitation on Postoperative ... Multimodal prehabilitation significantly reduced the risk of complications compared to standard care (OR: 0.60; 95% CI: 0.42-0.86; p=0.02).

5. jtcvs.org jtcvs.org/article/S0022-5223(25)00173-4/fulltext

The effect of multimodal prehabilitation on postoperative ... Multimodal prehabilitation significantly reduced overall and major postoperative 30-day complications in lung cancer surgery. It also contributed to reducing ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ... Malnutrition, even in its subclinical forms, significantly increases the risk of postoperative complications. It is estimated that ≤50% of patients undergoing ...

7. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-024-00359-x

Multidisciplinary prehabilitation to improve frailty and ... We examined the feasibility and safety of a pilot prehabilitation programme on high-risk frail patients undergoing major elective surgery.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04155346

Study Details | NCT04155346 | Prehab for Surgery Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery.

9. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2020/09000/two_week_multimodal_prehabilitation_program.26.aspx

Two-Week Multimodal Prehabilitation Program Improves... Surgical outcomes included short-term recovery quality, length of stay (LOS), chest tube duration, postoperative complications, and mortality, which were ...