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

Trial Summary

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

The available research shows that prehabilitation, which includes exercise and education before surgery, can improve outcomes after surgery. For example, patients who did exercise-based prehabilitation before total hip replacement surgery showed better physical functioning after surgery compared to those who did not. This included improvements in walking, getting up from a chair, and climbing stairs. In children, exercise-based prehabilitation also helped reduce complications after surgeries. However, education alone did not have a significant effect on outcomes. Overall, prehabilitation seems to be a promising approach to help patients recover better after surgery. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for reducing postoperative complications?

Research shows that prehabilitation, which includes exercise and education before surgery, can improve fitness and reduce complications after surgery. Exercise-based prehabilitation has been found to enhance physical functioning and reduce postoperative issues in both adults and children. ^{1 2 3 4 5}

What safety data exists for prehabilitation treatments?

The safety of prehabilitation treatments, including aerobic exercise and app-based interventions, is being actively studied. The PROTEGO MAXIMA trial is assessing the safety of an app-based endurance exercise program using wearables to monitor heart rate and distance. While prehabilitation is shown to improve cardiopulmonary fitness and reduce postoperative morbidity, more evidence is needed to establish its safety and effectiveness as routine clinical care. Ongoing large randomized clinical trials are expected to provide more substantial safety data. ^{3 6 7 8 9}

Is prehabilitation safe for humans?

Prehabilitation, which includes activities like aerobic exercise and preoperative education, is generally considered safe for humans. Studies have focused on its ability to improve fitness and reduce surgical complications, and while more research is needed, no significant safety concerns have been reported. ^{3 6 7 8 9}

Is the treatment of moderate aerobic exercise, pedometer, preoperative education, and text messages promising for reducing surgery complications?

Yes, this treatment is promising because it helps improve fitness before surgery, which can lead to fewer complications, better recovery, and improved quality of life after surgery. It prepares the body to handle the stress of surgery better, making recovery smoother and faster. ^{3 6 10 11 12}

How does the prehabilitation treatment differ from other treatments for reducing postoperative complications?

Prehabilitation is unique because it involves preparing patients for surgery through moderate aerobic exercise, education, and support like text messages, which can improve fitness and reduce complications. Unlike standard treatments, it focuses on enhancing the patient's physical and mental readiness before surgery, potentially leading to better recovery and fewer complications. ^{3 6 10 11 12}

What is the purpose of this trial?

While numerous studies have assessed the promising impacts of prehabilitation, there is a lack of prehabilitation research within lower socioeconomic patient populations. Often for prehabilitation studies, patients are heavily involved in full scale exercise and nutrition programs weeks before the scheduled procedure. In underserved populations, programs such as these are often not feasible due to lack of transport, resources, and other barriers to healthcare. The investigators seek to evaluate the effectiveness of inexpensive interventions in lower socioeconomic populations. The investigators hypothesize that barriers to prehabilitation are environmental and that prehabilitation interventions tailored for lower socioeconomic (SES) populations will improve time to discharge, mobility, and in turn, readmission rates. The participants for this clinical trial will be seen four times: initially at the preoperative surgical clinic (6-8 weeks prior to surgery), 1-2 days preop at a pre-procedure clinic, postoperative in the inpatient setting (as soon as the participant is able to ambulate during their hospital stay), and in the postoperative surgical clinic at the postoperative visit. Patients will be within the general surgery, colorectal, and surgical oncology departments at Boston Medical Center (BMC). The anticipated sample size is 60 participants (30 in the intervention/prehabilitation arm and 30 in the control/usual care arm). Participants in the intervention arm will participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. The control group will follow routine standard of care at BMC for preoperative and postoperative care.

Research Team

Nicole Spence, MD

Principal Investigator

Boston Medical Center, Anesthesiology Department

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review. [2022]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Preoperative aerobic exercise training in elective intra-cavity surgery: a systematic review. [2022]

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

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

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

Two novel prehabilitation apps to help patients stop smoking and risky drinking prior to hip and knee arthroplasty. [2023]

7. England 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. [2023]

8. United States 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. [2023]

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

The ability of prehabilitation to influence postoperative outcome after intra-abdominal operation: A systematic review and meta-analysis. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative morbidity]. [2014]

11. England 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. [2022]

12. United States 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. [2023]