Prehabilitation for Postoperative Complications

(Prehab Trial)

Overseen By Vaibhav Gupta, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Limited reading level

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special pre-surgery program to determine if it can speed up recovery and reduce hospital readmissions. It targets individuals who may lack easy access to exercise or health resources. Participants will engage in moderate aerobic exercise (simple exercises), use a pedometer (step tracker), and receive helpful tips via text messages. Ideal candidates are English or Spanish speakers who can walk unaided and have access to a cell phone with internet. The trial includes patients scheduled for general, colorectal, or cancer-related surgeries at Boston Medical Center. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance recovery for future surgical 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. It seems focused on mobility and step tracking interventions, so it's likely you can continue your medications, but please confirm with the trial coordinators.

Do I need to stop 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 these prehabilitation interventions are safe for lower socioeconomic populations?

A previous study showed that moderate aerobic exercise improves physical fitness and lowers the risk of lung problems after surgery, making recovery smoother without harm. Another study found that aerobic exercise did not increase post-surgery issues, suggesting it is generally safe.

Research on pre-surgery education has found it to be a common practice that aids recovery. It helps manage pain and can even reduce hospital stays, making it widely accepted as safe and beneficial for patients.

Text messages have also been studied for safety and usefulness. One study found that most patients experienced no problems when receiving text reminders before and after procedures, suggesting text messages are a safe way to support recovery.

Overall, these methods—exercise, education, and text messages—are generally well-tolerated and safe. They aim to ease surgery recovery and have been shown to work effectively without causing additional problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how prehabilitation might reduce postoperative complications, focusing on a blend of moderate aerobic exercise, pedometer use, preoperative education, and text message reminders. Unlike standard care that typically starts intervention post-surgery, this approach emphasizes preparation before surgery, potentially leading to better recovery outcomes. By incorporating technology like pedometers and text messages, this method promotes patient engagement and adherence, which could transform recovery protocols and enhance surgical outcomes.

What evidence suggests that this trial's prehabilitation interventions could be effective for improving postoperative outcomes in lower socioeconomic populations?

This trial will compare a prehabilitation approach with standard care. Research has shown that preparing for surgery with moderate exercise, which participants in the prehabilitation group will undertake, can significantly reduce postoperative problems and expedite hospital discharge. A review of studies found that exercising before surgery improves recovery and lowers the risk of complications. Participants in the prehabilitation group will also receive preoperative education, which studies indicate can shorten hospital stays and reduce postoperative issues by better preparing patients. Additionally, sending text message reminders, another component of the prehabilitation group, has proven to reduce the likelihood of hospital readmission and increase patient engagement in their care. When combined, these methods show promise in improving surgical outcomes, especially in resource-limited areas. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicole Spence, MD

Principal Investigator

Boston Medical Center, Anesthesiology Department

Are You a Good Fit for This Trial?

This trial is for English or Spanish speaking patients at Boston Medical Center who can walk without assistance and have surgery scheduled in 4-8 weeks. They must own a cell phone with internet and texting abilities, and score a JH-HLM of 6. It's not for those who cannot read beyond a 5th-grade level.

Inclusion Criteria

My surgery is planned for within the next 4 to 8 weeks.

I am a patient at Boston Medical Center's surgery or oncology department.

I can walk without the help of a cane, walker, or wheelchair.

Exclusion Criteria

Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants in the intervention arm participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. Control group follows routine standard of care.

6-8 weeks

1 visit (in-person) at preoperative surgical clinic, 1 visit (in-person) at pre-procedure clinic

Surgery and Postoperative Care

Participants undergo surgery and receive postoperative care. Intervention group continues mobility tracking.

Hospital stay (variable)

1 visit (inpatient setting)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including frailty scoring and mobility assessments.

8 weeks

1 visit (in-person) at postoperative surgical clinic

What Are the Treatments Tested in This Trial?

Interventions

• Moderate aerobic exercise
• Pedometer
• Preoperative education
• Text messages

Trial Overview The study tests if low-cost prehabilitation like moderate aerobic exercise, text message reminders, using pedometers, and preoperative education can help lower-income patients recover faster after surgery compared to standard care.

How Is the Trial Designed?

Group I: Prehabilitation group Experimental Treatment 4 Interventions

Watch a video created by the investigators, discussing exercise prior to surgery, receive text message reminders to begin exercise before surgery, and take walking tests before and after surgery.

Group II: Control group Active Control 1 Intervention

Receive the usual preoperative and post operative care and they will be provided a pedometer.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Published Research Related to This Trial

Prehabilitation before cardiac surgery significantly reduces the number of postoperative complications, with an odds ratio of 0.41 based on a systematic review of eight studies involving 3650 potential studies.

Patients who underwent prehabilitation showed a significant increase in maximal inspiratory pressure, indicating improved respiratory function, which may help them better cope with the stress of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of prehabilitation on post-surgical complications in patients undergoing non-urgent cardiovascular surgical intervention: Systematic review and meta-analysis. Marmelo, F., Rocha, V., Moreira-Gonçalves, D.[2022]

Prehabilitation, which includes physical exercise, nutritional, and psychological support before surgery, has been shown to improve cardiopulmonary fitness and reduce postoperative complications, leading to better recovery outcomes.

Current evidence suggests that individualized prehabilitation programs, which can be home-based or supervised in hospitals, are essential for maximizing effectiveness, although more research is needed to determine the optimal structure of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. Chmelo, J., Chmelová, I., Phillips, AW.[2021]

Preoperative exercise significantly reduces postoperative pain and improves function and quality of life within the first 6 months after joint replacement surgery, based on a systematic review of 28 studies, primarily focused on this type of surgery.

The review also indicates that preoperative exercise may lower the risk of postoperative complications, although its effects on other types of surgeries remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Exercise Has a Modest Effect on Postoperative Pain, Function, Quality of Life, and Complications: A Systematic Review and Meta-Analysis. Hayashi, K., Janowski, A., Lesnak, JB., et al.[2023]

The BeFitMe™ app was successfully redesigned for the Apple Watch, allowing frail, older patients to engage in prehabilitation without needing an iPhone or internet, which enhances accessibility for vulnerable populations.

User testing showed that 83% of participants responded to notifications, and data collection improved significantly, indicating that the app can effectively encourage physical activity in older patients before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-assisted behavioral intervention to encourage prehabilitation in frail older adults undergoing surgery: Development and design of the BeFitMe™ Apple Watch app. Kerstiens, S., Bender, EM., Rizzo, MG., et al.[2023]

Patients who participated in exercise-based prehabilitation before total hip arthroplasty showed significant improvements in postoperative physical functioning, as measured by tests like the six-minute walk test and Timed Up and Go test, compared to those who received no intervention.

Education alone did not improve postoperative outcomes, indicating that exercise therapy is the key component of effective prehabilitation, with no reported negative effects from the prehabilitation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Prehabilitation in Form of Exercise and/or Education in Patients Undergoing Total Hip Arthroplasty on Postoperative Outcomes-A Systematic Review. Widmer, P., Oesch, P., Bachmann, S.[2022]

A pilot study tested two prehabilitation apps aimed at helping patients reduce smoking and drinking before hip or knee surgery, with feedback indicating that while patients found the apps somewhat helpful, they did not lead to successful quitting.

Both apps received mixed reviews regarding usability and understanding, highlighting the need for significant improvements and additional support from addiction specialists to enhance their effectiveness in reducing preoperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two novel prehabilitation apps to help patients stop smoking and risky drinking prior to hip and knee arthroplasty. Tønnesen, H., Raffing, R., Lauridsen, SV., et al.[2023]

Exercise-based prehabilitation programs have shown positive effects on postoperative outcomes in children, particularly in reducing complications after elective surgeries, based on a review of three studies.

Despite limited literature, the evidence suggests that prehabilitation can enhance functional capacity and pulmonary function in children post-surgery, indicating its potential as a beneficial therapeutic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review. Noronha, J., Samuel, S., Singh, VP., et al.[2022]

Preoperative aerobic exercise training may improve physical fitness in patients awaiting intra-cavity surgery, with eight out of ten studies showing positive results in at least one fitness measure.

While evidence for improved postoperative clinical outcomes is limited, one study indicated that aerobic training could reduce hospital and intensive care stay after cardiac surgery, suggesting potential benefits in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative aerobic exercise training in elective intra-cavity surgery: a systematic review. O'Doherty, AF., West, M., Jack, S., et al.[2022]

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]

Prehabilitation, which includes exercises like inspiratory muscle training and aerobic workouts, significantly reduces the risk of postoperative complications after intra-abdominal surgeries, with an odds ratio of 0.59 based on a systematic review of multiple studies.

While the impact of prehabilitation on the length of hospital stay remains uncertain due to limited data, no postoperative mortality was reported, indicating a potential safety benefit of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ability of prehabilitation to influence postoperative outcome after intra-abdominal operation: A systematic review and meta-analysis. Moran, J., Guinan, E., McCormick, P., et al.[2022]

Prehabilitation, which involves physical exercise before surgery, can significantly improve postoperative recovery and reduce complications, especially in elderly patients with poor preoperative functional status.

An effective prehabilitation program typically includes three sessions per week of endurance and muscle reinforcement exercises for six to eight weeks prior to surgery, enhancing overall patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative morbidity]. Debes, C., Aissou, M., Beaussier, M.[2014]

The PROTEGO MAXIMA trial is evaluating an app-based endurance exercise program designed to improve physical fitness in patients before major surgery, with a focus on usability, validity, and safety using wearable technology to monitor heart rate and distance.

The study will assess the correlation between prehabilitation and postoperative complications, aiming to demonstrate that improved fitness through the app can lead to better surgical outcomes and reduced hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot trial analysing the usability, validity and safety of an interventional health app programme for the structured prehabilitation of patients before major surgical interventions: the PROTEGO MAXIMA trial. Faqar-Uz-Zaman, SF., Sliwinski, S., Detemble, C., et al.[2023]

Citations

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

Prehabilitation: Impact on Postoperative Outcomes - PMC A recent systematic review of unimodal exercise prehabilitation concluded that prehabilitation reduced postoperative complications and length ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144058/

Effects of perioperative exercise therapy on cardiorespiratory ... This systematic review and meta-analysis evaluated the effects of perioperative exercise therapy (aerobic, resistance, mind–body, flexibility, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879406825000967

Effect of preoperative exercise on postoperative ... In a randomised controlled trial, high-intensity aerobic exercise together with strength training for just three weeks decreased the risk of postoperative ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806718

Association of Preoperative High-Intensity Interval Training ... There was moderate evidence that preoperative HIIT reduces the odds of postoperative complications by 56% (OR, 0.44; 95% CI, 0.32-0.60; P < .001) ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.628848/full

A Systematic Review and Meta-Analysis A recent study found similar improvements in preoperative functional capacity using high-intensity interval training (HIIT) compared to moderate ...

6. mhealth.jmir.org mhealth.jmir.org/2025/1/e55298

Validity, Accuracy, and Safety Assessment of an Aerobic ... The PROTEGO MAXIMA trial was a prospective interventional pilot trial assessing the validity, accuracy, and safety of an app-based exercise program.

7. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.202002-183OC

Preoperative Exercise Training to Prevent Postoperative ... Preoperative exercise training improves physical fitness and reduces the risk of developing PPCs while minimizing hospital resources use.