Exercise and Nutrition for Surgical Complications

Overseen By Kenneth Ogan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

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

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

Is exercise and nutrition generally safe for humans?

Exercise and nutrition, when done properly, are generally safe for humans. Proper hydration and balanced nutrition are important for maintaining health during physical activity, and supplements should be used cautiously and evaluated for safety. ^{1 2 3 4 5}

How does the treatment of exercise and nutrition for surgical complications differ from other treatments?

This treatment is unique because it combines exercise and nutrition to potentially reduce surgical complications, focusing on improving overall physical health and recovery, unlike traditional treatments that may focus solely on medication or surgery. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Exercise and Nutrition for Surgical Complications?

Research suggests that early physical training after surgery can help maintain muscle strength and reduce hospital stay, while adequate protein intake is important to prevent muscle loss. Additionally, preoperative exercise may improve physical fitness and reduce complications after major abdominal surgery. ^{11 12 13 14 15}

Who Is on the Research Team?

Kenneth Ogan, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients scheduled for urologic surgery with an inpatient stay. They must be willing to sign consent, fill out questionnaires, give blood samples as part of standard care, and keep a daily log of their steps or supplement intake.

Inclusion Criteria

I will fill out the step log every day.

I am scheduled for surgery that requires staying in the hospital afterwards.

Patients willing and able to give blood sample as part of standard of care labs

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Baseline

Participants continue their current lifestyle for two days to establish baseline activity and nutritional risk

2 days

1 visit (in-person)

Intervention

Participants follow either a physical fitness plan or a nutrition plan until surgery

Up to 50 days

Regular self-monitoring

Follow-up

Participants are monitored for changes in physical function and perioperative complications

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Group
• Nutrition Group

Trial Overview The study tests two approaches to reduce complications after surgery: one group follows a physical fitness plan aiming for 10,000 steps per day plus strength training three times weekly; the other consumes nutritional supplements twice daily.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

Participants randomized to the activity intervention will aim for taking 10,000 steps per day and completing strength training exercises three times per week.

Group II: Nutrition Group Active Control 1 Intervention

Participants randomized to the nutrition intervention will consume a liquid over-the-counter nutrition supplement two times per day.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

vmaster

Collaborator

Trials

1

Recruited

400+

Published Research Related to This Trial

Early intensive physical training after major surgery can help maintain muscle mass and strength, as well as improve functional performance and reduce hospital stay duration.

Adequate protein intake is crucial for postoperative recovery, as it helps combat the muscle degradation that often occurs due to surgery and immobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The physically-inactive surgical patient]. Kjaer, M., Suetta, C., Tønnesen, H.[2006]

In a study of 119 patients aged 60 and older undergoing elective colorectal surgery, those who engaged in muscular strength training showed a significant increase in lean body mass (LBM) at 7 days post-surgery compared to those who did non-strengthening exercises, with a difference of 1.2 kg (P=0.03).

Overall, while physical training had a minor impact on body composition, it did not significantly enhance nutritional intake in well-nourished patients during the postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Little effect of physical training on body composition and nutritional intake following colorectal surgery--a randomised placebo-controlled trial. Houborg, KB., Jensen, MB., Hessov, I., et al.[2006]

Postoperative physical training significantly reduced fatigue in patients after elective colorectal surgery, particularly by day seven, compared to those who only received relaxation exercises.

However, the training did not lead to improvements in physical function, as all measures of physical performance returned to preoperative levels by day 90, indicating that while fatigue may be alleviated, overall physical recovery was similar between training and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative physical training following colorectal surgery: a randomised, placebo-controlled study. Houborg, KB., Jensen, MB., Rasmussen, P., et al.[2017]

Postoperative nutrition interventions, including the use of fish oils and strategies to prevent dysbiosis, can optimize recovery outcomes in patients undergoing oncologic, orthopedic, and cardiac surgeries.

Implementing graduated early enteral feeding and supporting the microbiome are essential strategies to mitigate the metabolic stress response from surgery and enhance immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel nutrition strategies to enhance recovery after surgery. Martindale, RG.[2023]

Preoperative exercise therapy (PEXT) may improve physical fitness in patients before major abdominal surgery (MAS), potentially leading to better recovery outcomes.

While some studies suggest that preoperative chest physiotherapy can reduce pulmonary complications after surgery, there is still no consensus on the most effective exercise regimen for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative exercise therapy for elective major abdominal surgery: a systematic review. Pouwels, S., Stokmans, RA., Willigendael, EM., et al.[2022]

Athletes commonly use dietary supplements to address nutritional needs and improve performance, but many take them in high doses that exceed normal dietary levels.

Research has shown that carbohydrate-electrolyte sports drinks are effective for hydration and energy during exercise, with optimal glucose solutions demonstrating suitable gastric emptying, although the ideal sodium concentration for these drinks remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplements in sport. Burke, LM., Read, RS.[2018]

Optimal nutrition is crucial for enhancing physical activity, athletic performance, and recovery, with specific recommendations on food selection, timing, and hydration for athletes based on a systematic review of current scientific data.

Athletes should focus on meeting their energy and macronutrient needs, particularly carbohydrates and proteins, to support performance and recovery, while being cautious with supplements and seeking guidance from qualified sports dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and athletic performance. Rodriguez, NR., DiMarco, NM., Langley, S.[2022]

Glucosamine sulfate and chondroitin sulfate are effective for osteoarthritis, with fewer side effects than traditional anti-inflammatory drugs, and are the only treatments shown to prevent disease progression based on sufficient controlled trials.

Many weight loss supplements, including ephedrine and phenylpropanolamine, have safety concerns due to associated deaths, while others lack sufficient evidence for efficacy, highlighting the need for more rigorous studies on dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and dietary supplements. Fillmore, CM., Bartoli, L., Bach, R., et al.[2008]

In a study involving 8 trained male runners, consuming a beef nutritional supplement post-exercise did not negatively impact hydration status, blood pressure, or running economy, indicating it is a safe recovery option.

The beef supplement provided adequate sodium intake without leading to significant changes in urine volume or specific gravity, suggesting it can effectively support recovery without adverse effects on hydration or performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydration Status and Sodium Balance of Endurance Runners Consuming Postexercise Supplements of Varying Nutrient Content. Pryor, JL., Johnson, EC., Del Favero, J., et al.[2015]

Optimal nutrition is essential for enhancing physical activity, athletic performance, and recovery, with specific recommendations on food selection, timing, and hydration for athletes based on a systematic review of current scientific data.

Athletes should focus on meeting their energy and macronutrient needs, particularly carbohydrates and proteins, while being cautious with supplements and ergogenic aids, and should seek guidance from qualified sports dietitians for personalized nutrition plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Sports Medicine position stand. Nutrition and athletic performance. Rodriguez, NR., Di Marco, NM., Langley, S.[2022]

Women who took a specially formulated postpartum recovery supplement after vaginal delivery showed significantly better pelvic floor recovery compared to those who only took a regular prenatal vitamin, with less frequent weak pelvic floor muscle strength (28% vs. 58%).

The treatment group also experienced fewer levator muscle injuries and lower rates of anterior vaginal wall prolapse and bothersome bulge symptoms at 6 weeks postpartum, indicating the supplement's effectiveness in promoting pelvic floor health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for improved recovery of the pelvic floor after vaginal delivery with a specially formulated postpartum supplement. Takacs, P., Kozma, B., Lampé, R., et al.[2022]

A randomized controlled trial involving 51 women undergoing surgery for prolapse or hysterectomy found that a supervised pelvic floor muscle training program did not significantly improve bladder or prolapse symptoms compared to usual care after 12 months.

The lack of improvement may be attributed to factors such as the effectiveness of the surgery itself, variability in the data, the small sample size, and potential training received by the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Frawley, HC., Phillips, BA., Bø, K., et al.[2022]

Proper diet and physical activity, including Kegel and core stability exercises, are important preventive measures against female genital prolapse and urinary incontinence, which affect 50% of women over 50.

Visceral therapy, aimed at restoring organ mobility and improving circulation, is gaining recognition as a complementary treatment alongside traditional methods in gynecology and physiotherapy for pelvic support disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of visceral therapy, Kegel's muscle, core stability and diet in pelvic support disorders and urinary incontinence - including sexological aspects and the role of physiotherapy and osteopathy. Wojcik, M., Jarzabek-Bielecka, G., Merks, P., et al.[2023]

A study involving 200 nulliparous women found that pelvic floor muscle exercises (PFME) during pregnancy did not significantly improve female sexual function or childbirth outcomes compared to routine antenatal care alone.

Despite some trends, such as slightly higher sexual satisfaction in the control group three months post-birth, the low adherence rate of 50% to PFME suggests that further research is needed to fully understand its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of antenatal pelvic floor muscle exercise on sexual function and labour and birth outcomes: A randomised controlled trial. Sobhgol, SS., Smith, CA., Thomson, R., et al.[2022]

In a study of 83 women with pelvic organ prolapse, adding pelvic floor muscle training to a lifestyle advice program did not significantly improve overall symptom relief compared to lifestyle advice alone after 12 months.

While both groups showed some improvement in specific symptoms, a higher percentage of women in the lifestyle group (70%) sought further treatment compared to those in the training and lifestyle group (48%), indicating that the additional training may not have provided substantial long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 12-month effects of structured lifestyle advice and pelvic floor muscle training for pelvic organ prolapse. Due, U., Brostrøm, S., Lose, G.[2018]

Citations

1. Denmark pubmed.ncbi.nlm.nih.gov

[The physically-inactive surgical patient]. [2006]

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

Little effect of physical training on body composition and nutritional intake following colorectal surgery--a randomised placebo-controlled trial. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Postoperative physical training following colorectal surgery: a randomised, placebo-controlled study. [2017]

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

Novel nutrition strategies to enhance recovery after surgery. [2023]

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Preoperative exercise therapy for elective major abdominal surgery: a systematic review. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Dietary supplements in sport. [2018]

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

Position of the American Dietetic Association, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and athletic performance. [2022]

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

Nutrition and dietary supplements. [2008]

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

Hydration Status and Sodium Balance of Endurance Runners Consuming Postexercise Supplements of Varying Nutrient Content. [2015]

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

American College of Sports Medicine position stand. Nutrition and athletic performance. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for improved recovery of the pelvic floor after vaginal delivery with a specially formulated postpartum supplement. [2022]

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

Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. [2022]

13. Poland pubmed.ncbi.nlm.nih.gov

The role of visceral therapy, Kegel's muscle, core stability and diet in pelvic support disorders and urinary incontinence - including sexological aspects and the role of physiotherapy and osteopathy. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of antenatal pelvic floor muscle exercise on sexual function and labour and birth outcomes: A randomised controlled trial. [2022]

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

The 12-month effects of structured lifestyle advice and pelvic floor muscle training for pelvic organ prolapse. [2018]