Prehabilitation Program for Abdominal Plastic Surgery

Not currently recruiting at 1 trial location

Overseen By Cara Black, PGY-2

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English speakers, No smartphone, Other intervention, others

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

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a prehabilitation program to determine if physical and mental preparation before and after abdominal plastic surgery can improve recovery. The study aims to discover whether a program focused on fitness and nutrition enhances surgical outcomes and patient engagement. Participants will either follow a specific pre-surgery workout and nutrition plan or receive standard advice. Ideal candidates are adults scheduled for elective abdominal plastic surgery in the next few weeks with certain surgeons and who have access to a smartphone or the internet.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance recovery experiences for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for patients undergoing abdominal plastic surgery?

Research has shown that prehabilitation programs are generally safe and well-tolerated by patients. These programs aim to improve health before surgery. A review of these programs found they enhance physical fitness and nutrition without causing major side effects. Studies suggest that prehabilitation aids recovery after major surgeries, such as abdominal procedures, by preparing patients both physically and mentally.

While some safety data on prehabilitation varies, most findings support its safety. Participants usually experience minimal side effects. The goal is to strengthen and improve patients' health before surgery, potentially leading to better outcomes. Overall, for those considering a trial with a prehabilitation program, current evidence suggests it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of a prehabilitation program before abdominal plastic surgery. Unlike the standard preoperative care, which typically involves basic advice on nutrition and fitness, this program aims to actively engage patients in abdominal workouts and surveys at least two weeks before surgery. This proactive approach could enhance physical conditioning and potentially improve recovery outcomes, offering a new dimension to pre-surgery preparation. By focusing on targeted exercises, it may help patients build strength and resilience, possibly leading to quicker recovery times and better overall surgical results.

What evidence suggests that this prehabilitation program is effective for improving outcomes in abdominal plastic surgery?

Research has shown that preparing for surgery with exercise and nutrition programs, known as prehabilitation, can enhance recovery. In this trial, participants in the Prehab Intervention Arm will access a prehabilitation program, which includes abdominal workout videos and surveys. Studies have found that prehabilitation reduces surgical stress and prepares patients effectively. This preparation can lead to improved physical abilities and shorter hospital stays. While some studies suggest that more frequent supervised sessions can boost physical abilities, they do not significantly alter overall surgical outcomes. Overall, prehabilitation helps patients feel more prepared and may improve recovery after abdominal plastic surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Cara Black, MD

Principal Investigator

Resident

Cindy Kin, MD

Principal Investigator

Asst Prof-Med Ctr Line

Are You a Good Fit for This Trial?

This trial is for adults over 18 planning to have elective abdominally-based plastic surgery in at least 3 weeks by specific surgeons. Participants must speak English and have access to a smartphone or internet. Those involved in other nutrition/exercise studies can't join.

Inclusion Criteria

I am over 18 and scheduled for elective abdominal surgery with a specified surgeon in 3+ weeks.

Exclusion Criteria

Patients who do not have access to a smartphone or internet/cell service

Patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a prehabilitation program to optimize physical fitness and nutrition before surgery

2 weeks

1 visit (virtual)

Surgery

Participants undergo abdominally-based plastic surgery

1 day

Post-operative Recovery

Participants are monitored for recovery and surgical outcomes

12 months

Multiple visits (in-person and virtual) over 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation Program

Trial Overview The study tests if a 'prehabilitation' program, focusing on improving physical fitness and nutrition before and after surgery, leads to better recovery outcomes from abdominally-based plastic surgeries.

How Is the Trial Designed?

Group I: Prehab Intervention Arm Experimental Treatment 1 Intervention

The intervention arm will receive access to the prehab program (abdominal workout videos) and surveys via RedCAP.The program will start no less than 14 days before the date of surgery.

Group II: Control Active Control 1 Intervention

The control arm will receive no additional prehabilitation material prior to material. Rather, they will receive standard preoperative care in which they will be given standard advice on nutrition and fitness. REDcap surveys will be administered.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

Prehabilitation is a promising approach that prepares patients for major abdominal surgeries by improving their overall health and functional capacity, potentially leading to better postoperative outcomes.

The study reviews various methods for selecting patients for prehabilitation programs and suggests implementation strategies, highlighting its importance in reducing stress and adverse effects associated with surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation: how to prepare our patients for elective major abdominal surgeries? Gonçalves, CG., Groth, AK.[2020]

A systematic review of 33 studies involving 3167 citations found that prehabilitation did not significantly improve postoperative function, quality of life, or pain in patients undergoing knee or hip arthroplasty for osteoarthritis.

However, prehabilitation programs lasting over 500 minutes may reduce the need for postoperative rehabilitation, indicating a potential benefit in healthcare utilization, even though no significant reductions in readmissions or nursing home placements were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. Cabilan, CJ., Hines, S., Munday, J.[2022]

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]

A multimodal prehabilitation program combining exercise, nutritional support, and mindfulness training was successfully implemented in patients preparing for elective cardiac surgery, with 45 days of participation and no reported complications.

The program significantly improved patients' functional capacity, as shown by increased performance in the six-minute walking test and chair test, suggesting potential benefits for recovery after surgery, although further research is needed to confirm its impact on postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of prehabilitation in cardiac surgery. Preliminary study. López-Hernández, A., Arguis, MJ., Gimeno-Santos, E., et al.[2023]

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]

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 4-week prehabilitation program involving physical therapy, nutritional support, and psychological preparation was safely implemented in 60 out of 106 patients scheduled for major abdominal surgery, with no cardiovascular events reported during the program.

Patients showed significant improvements in physical function (6-minute walking distance increased by 9.3%) and psychological well-being, suggesting that prehabilitation can enhance recovery and quality of life before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation before major abdominal surgery: Evaluation of the impact of a perioperative clinical pathway, a pilot study. Boukili, IE., Flaris, AN., Mercier, F., et al.[2022]

Prehabilitation, which focuses on improving patients' functional capacity and managing risks before surgery, has been shown to reduce post-operative complications and improve overall outcomes in various surgical procedures, including lung cancer resection and coronary artery bypass grafting.

Incorporating prehabilitation alongside traditional rehabilitation not only enhances physical function but also lowers the risk of adverse events, helping patients return to normal activities more effectively after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation Coming of Age: IMPLICATIONS FOR CARDIAC AND PULMONARY REHABILITATION. Myers, J., Niebauer, J., Humphrey, R.[2023]

A systematic review of eight randomized controlled trials involving 442 patients found that preoperative exercise training significantly reduced postoperative pulmonary complications and overall morbidity compared to standard care.

Despite the benefits in reducing complications, prehabilitation did not significantly shorten the length of hospital stay, indicating that while it improves recovery, it may not affect hospitalization duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-analysis of Physical Exercise Prehabilitation in Major Abdominal Surgery (PROSPERO 2017 CRD42017080366). Heger, P., Probst, P., Wiskemann, J., et al.[2021]

A systematic review of 16 studies involving 2591 patients found that total body prehabilitation, which includes exercise, nutrition, and psychological support, can reduce post-operative complications in major abdominal surgery, particularly in malnourished patients.

A multimodal prehabilitation approach appears to improve functional outcomes more effectively than single-modality programs, but the variability in study designs means there is not enough data to recommend a specific prehabilitation protocol for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Total Body Prehabilitation on Post-Operative Outcomes After Major Abdominal Surgery: A Systematic Review. Luther, A., Gabriel, J., Watson, RP., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04787874

Study Details | NCT04787874 | Effect of Prehabilitation on ... The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9924929/

Prehabilitation in Patients before Major Surgery: A Review ... Prehabilitation decreases the surgical stress response and increases the preparedness of the patient to undergo planned surgical insult. Preoperatively ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36736208/

Efficacy of supervised exercise prehabilitation programs to ... Prehabilitation programmes with more than one supervised session per week improved physical function but did not enhance surgical outcomes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424007662

The Impact of Surgical Prehabilitation on Postoperative ... Prehabilitation interventions have the potential to improve postoperative outcomes, including physical function and LOS in surgical patients.

5. researchgate.net researchgate.net/publication/277352524_Optimization_of_surgical_outcomes_with_prehabilitation

(PDF) Optimization of surgical outcomes with prehabilitation Prehabilitation, a term used to encompass pre-operative education and exercise, increases patients' preparedness for surgery, reduces recovery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8649915/

Feasibility of a prehabilitation program before major ... To assess the feasibility of a prehabilitation program and its effects on physical performance and outcomes after major abdominal surgery.

7. researchgate.net researchgate.net/publication/326777172_Prehabilitation_before_Major_Abdominal_Surgery_A_Systematic_Review_and_Meta-Analysis

Prehabilitation before Major Abdominal Surgery However, there is conflicting data on safety outcomes of revisional procedures. We aim to characterize patient demographics, procedure type ...

8. bmj.com bmj.com/sites/default/files/attachments/bmj-article/pre-pub-history/original_submission_07-jun-2024.pdf

Confidential: For Review Only Objective: To estimate the relative efficacy of individual, and combinations of, prehabilitation components. (exercise, nutrition, cognitive and ...