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?

This trial explores how exercise and nutrition can reduce complications after surgery. Participants will be divided into two groups: one focusing on physical activity and the other on nutrition. The exercise group aims for 10,000 steps a day and strength training three times a week, while the nutrition group will consume a nutrition supplement like Boost or Ensure twice daily. Candidates for this trial include those about to undergo surgery with a hospital stay who can track their steps or supplement intake. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance recovery outcomes for future surgical patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the exercise and nutrition plans tested in this trial are safe for participants.

For the exercise group, studies on activities such as walking and strength training indicate they are generally manageable. Regular exercise is often recommended to improve overall health and typically does not cause serious side effects.

For the nutrition group, research on the supplements used in this trial has shown they are safe and can help reduce post-surgery complications, such as infections. These supplements are commonly used and are generally safe for most individuals.

Overall, these plans have a good safety record in similar contexts. However, individual experiences may vary, so participants should consult the trial team or their doctor if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise and Nutrition interventions for surgical complications because they take a holistic approach to recovery, which is quite different from traditional methods like medication and bed rest. The Exercise Group aims to promote physical activity by encouraging participants to walk 10,000 steps daily and engage in strength training, which can enhance physical resilience and potentially reduce recovery time. The Nutrition Group focuses on boosting nutritional intake with an over-the-counter supplement, which could help improve patients' overall health and healing capacity. These interventions represent a shift towards empowering patients to actively contribute to their recovery process, potentially leading to better outcomes.

What evidence suggests that this trial's treatments could be effective for reducing surgical complications?

This trial will compare the effects of exercise and nutrition interventions on surgical complications. Participants in the Exercise Group will aim to take 10,000 steps daily and complete strength training exercises three times a week. Research has shown that exercise greatly benefits health, with activities like walking and strength training strengthening muscles and improving body function.

Participants in the Nutrition Group will consume a liquid over-the-counter nutrition supplement twice daily. Studies suggest that nutritional supplements before surgery can help reduce the risk of infections and other post-surgery complications. Both exercise and good nutrition have shown promising results in aiding surgical patients' recovery. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9142907/

Effects of Pelvic-Floor Muscle Training in Patients with ... A PFMT program is an effective way to improve the pelvic, urinary, and intestinal symptoms associated with POP; function of the pelvic floor; and quality of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07048145

Effects of Kegel Ball and Pelvic Floor Exercises on Sexual ... Preliminary findings suggest that regular pelvic floor muscle training may improve urinary control and enhance sexual function through improved muscle strength ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301414/

Effectiveness of Pelvic Floor Muscle Training on Quality ... This study confirmed the effectiveness of PFMT on the QoL in women with UI, mainly for patients with stress urinary incontinence.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211511003952

Evaluation of the effect of pelvic floor muscle training ... In a study [12], the effect of PFMT on SUI and mixed urinary incontinence was evaluated. PFMT for 8 weeks, could improve significantly the pelvic floor muscle ...

5. academic.oup.com academic.oup.com/ptj/article/99/1/109/5134171

Predictors of Success for Pelvic Floor Muscle Training in ... The objective of this study was to identify factors that predict treatment success in women receiving pelvic floor muscle training for prolapse.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2468784723001551

Physiotherapy interventions in the treatment of pelvic floor ... Overall, pelvic floor training appears to be an effective technique in the treatment of pelvic floor dysfunction after the treatment of gynaecological ...

7. urology.stanford.edu urology.stanford.edu/content/dam/sm/urology/JJimages/publications/Pelvic-floor-physical-therapy-in-the-treatment-of-pelvic-floor-dysfunction-in-women.pdf

Pelvic floor physical therapy in the treatment of pelvic floor ... Based on the available evidence, PFPT with or without supplemental modalities can improve or cure symptoms of urinary incontinence, POP, fecal incontinence, ...