Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery

NCT04073381 | Completed Early Phase 1

• 1 other identifier: 2018-08-0110
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to measure surgical recovery, including the length of hospital stay, incidence of perioperative complications, and mortality at 90 days post-surgery, in surgical patients with abdominal cancer. The investigators hypothesize that this prehabilitation program will improve recovery and reduce perioperative complications via the proposed prehabilitation intervention.

Conditions

Prehabilitation

Keywords

Blood Flow Restriction Training; Ergogenic Aids; Abdominal Cancer

Outcome Measures

Primary Outcomes (4)

• Hospital Measures- Length of hospital stay

  Length of hospital stay

  Through study completion, an average 1year

• Hospital Measures- Emergency room visits

  emergency room visits

  Through study completion, an average 1 year

• Hospital Measures- Readmission

  Readmission

  Through study completion, an average 1 year

• Hospital Measures

  Mortality

  Through study completion, an average 1 year

Secondary Outcomes (21)

• Physical Fitness- Hand Grip

  Baseline, 4 weeks, and 8 weeks

• Physical Fitness- 6MWT

  Baseline and 4 weeks

• Physical Fitness- TUG

  Baseline, 4 weeks, and 8 weeks

• Physical Fitness- SPPB

  Baseline and 4 weeks

• Body Composition

  Baseline and 4 weeks

Study Arms (1)

Prehabiliation Program

EXPERIMENTAL

100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study ad participate in the prescribed prehabilitation exercise and nutrition program.

Combination Product: Prehabilitation Program

Interventions

Prehabilitation Program COMBINATION_PRODUCT

This is a 4 week prehabilitation program which uses both exercise and nutrition. Exercise will be prescribed at least 6 days a week. Three days a week , for 45 mins, participants will be asked to perform body, leg and arm exercises against light resistance while wearing pneumatic blood flow restriction arm and leg bands. minutes. On the alternate days participants will walk approximately 15 minutes while wearing the leg bands that restrict blood flow. Additionally, a nutrition supplement cocktail will be provided and should be taken every day within 1 hour after completing each exercise session. The 4 Week Nutrition (Sports Drink) Supplement Cocktail: will include whey protein (25 g/day), creatine monohydrate (8 g/day), and L-citrulline (5 g/day). The supplement mixture will be provided in daily packages by the investigators (nutrition supplements are not regulated by the FDA)

Prehabiliation Program

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients certified by a surgeon to participate in this study;
• Patients between the ages of 18 and 90;
• Patients with GI cancer.

You may not qualify if:

• Uncontrolled or active angina;
• New York Heart Association Class 3 or 4 heart failure;
• A myocardial infarction within the last 6 months;
• Severe/ uncontrolled hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥120mmHg);
• Uncontrolled diabetes (fasting blood glucose \>400 mg/dL);
• American Society of Anesthesiologists (ASA) health status grade IV-V.
• Severe orthopedic conditions that prohibit or impede exercise;
• Wheelchair dependence;
• Co-morbid medical conditions interfering with the ability to perform exercise; -Severely impaired ambulation (i.e. patients with uncontrolled neuromuscular disorders);
• History of Acute Deep Venous Thrombosis within the last 6 months;
• Inability to comply with exercise instructions upon evaluation; or
• Inability to provide an informed consent (dementia);
• Taking medication/supplements containing nitrites/nitrates;
• With allergies to creatine monohydrate;
• With allergies or intolerance to artificial sweeteners such as Sucralose, Xylitol, Aspartame, or Stevia;

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Cardiovascular Aging Research Laboratory at UT Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Wooten SV, Wolf JS Jr, Mendoza D, Bartholomew JB, Stanforth PR, Stanforth D, Tanaka H, Fleming RYD. The Impact of a Multimodal Sport Science-Based Prehabilitation Program on Clinical Outcomes in Abdominal Cancer Patients: A Cohort Study. Am Surg. 2022 Sep;88(9):2302-2308. doi: 10.1177/00031348221103657. Epub 2022 May 24.

  PMID: 35608376 DERIVED

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study. 100 is an arbitrary number of participants. Due to this study design not being previously use before power analysis calculations were unable to made for key variables. All subjects will participate in the study design.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: August 29, 2019
• Study Start: October 28, 2018
• Primary Completion: July 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)