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

Primary Purpose

Prehabilitation

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation Program
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehabilitation focused on measuring Blood Flow Restriction Training, Ergogenic Aids, Abdominal Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria: Patients with

  • 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;
  • Simultaneous participation in a pharmacotherapy trial;
  • Estimated glomerular filtration rate (EGFR) < 30 and not currently on dialysis.
  • Pregnant or lactating women
  • Dementia
  • Mini Mental State Examination score of Severe Impairment (≤17), or
  • Patients with severe depression.

Sites / Locations

  • Cardiovascular Aging Research Laboratory at UT Austin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabiliation Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Hospital Measures- Length of hospital stay
Length of hospital stay
Hospital Measures- Emergency room visits
emergency room visits
Hospital Measures- Readmission
Readmission
Hospital Measures
Mortality

Secondary Outcome Measures

Physical Fitness- Hand Grip
Hand grip dynamometry
Physical Fitness- 6MWT
6 minute walk test
Physical Fitness- TUG
Timed up and go
Physical Fitness- SPPB
Short Physical Performance Battery Assessing Lower Extremity Function
Body Composition
DXA (dual energy X-ray absorptiometry) will be used to assess body composition.
Blood Work- AA
Amino Acids
Blood Work- CRP
C-Reactive protein (CRP)
Blood Work- IL6
Interleukin 6 (IL-6)
Blood Work- TNFalpha
TNF-alpha
Questionnaires- Health Status
Health research questionnaire; self reported medical and health history of participant.
Questionnaires- IPAQ
International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.
Questionnaires- SF36
SF-36 Quality of Life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Questionnaires- MMSE
Mini Mental State Examination (MMSE) 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Score is reported as 0-30 . 24-30 indicates no cognitive impairment, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment.
Questionnaires- FESI
Falls Efficacy Scale-International; items are summed to calculate a range of total score from minimum 16 to maximum 64. The higher the score the greater the fear of falling.
Questionnaires- Nutrition
Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.
Questionnaires- Charlson Comorbidity
Charlson Comorbidity Index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality.
Questionnaires- BSCI
Brief Screen for Cognitive Impairment (BSCI); Scores are weighted and summed to arrive at final score. Delayed recall and medication help each get a weight of 2.0, and errand help gets a weight of 1.0. If client does not take any medications, the weighted scores of the other two items perform similarly to the three-item version. Higher scores indicate greater frailty/cognitive impairment.
Questionnaires- Edmonton Frailty
Edmonton Frailty Assessment; consists of nine domains and eleven items, each scoring 0 points (frailty absent or normal health), 1 point (minor errors or mild/moderate impairment), or 2 points (important errors or severely impaired). Higher scores indicate greater frailty.
Questionnaires- ECOG
Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.
Questionnaires- Clock Test
Clock Test; evaluates three items: "correctly drawn clock shape," "all numbers in the correct position," and "hands of the clock set to the correct time." A score of 1 was assigned for each of these items. Higher scores indicate greater frailty/cognitive impairment.
Accerlometry
Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery.

Full Information

First Posted
July 8, 2019
Last Updated
July 4, 2021
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04073381
Brief Title
Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
Official Title
Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators propose that steps to augment and optimize the effectiveness of prehabilitation interventions for abdominal cancer patients may be found in the field of sport science. The investigators have identified two primary strategies to improve and optimize prehabilitation in patients with abdominal cancer: exercise and nutritional supplementation. A home-based exercise program incorporating both walking and resistance training will be performed with blood flow restriction training (BFR). BFR is a cutting-edge training modality that works by restricting blood flow out of the veins by using compression devices similar to traditional blood pressure cuffs (1). This training modality is frequently used by injured athletes for enhanced recovery (2). Muscle hypertrophy and increased muscle strength are more robust and achievable with BFR, even if exercises are performed at low to moderate intensities (2). Additionally, the implementation of a sports nutrition supplement cocktail, which will be provided simultaneously with the 4-week BFR exercise intervention, was developed to augment the effects of resistance exercise by increasing overall anabolism (3) and to remedy the catabolic state that cancer patients often experience (4). The nutrition supplement cocktail will include whey protein, creatine monohydrate, and L-citrulline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehabilitation
Keywords
Blood Flow Restriction Training, Ergogenic Aids, Abdominal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehabiliation Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Prehabilitation Program
Intervention Description
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)
Primary Outcome Measure Information:
Title
Hospital Measures- Length of hospital stay
Description
Length of hospital stay
Time Frame
Through study completion, an average 1year
Title
Hospital Measures- Emergency room visits
Description
emergency room visits
Time Frame
Through study completion, an average 1 year
Title
Hospital Measures- Readmission
Description
Readmission
Time Frame
Through study completion, an average 1 year
Title
Hospital Measures
Description
Mortality
Time Frame
Through study completion, an average 1 year
Secondary Outcome Measure Information:
Title
Physical Fitness- Hand Grip
Description
Hand grip dynamometry
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Physical Fitness- 6MWT
Description
6 minute walk test
Time Frame
Baseline and 4 weeks
Title
Physical Fitness- TUG
Description
Timed up and go
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Physical Fitness- SPPB
Description
Short Physical Performance Battery Assessing Lower Extremity Function
Time Frame
Baseline and 4 weeks
Title
Body Composition
Description
DXA (dual energy X-ray absorptiometry) will be used to assess body composition.
Time Frame
Baseline and 4 weeks
Title
Blood Work- AA
Description
Amino Acids
Time Frame
Baseline and 4 weeks
Title
Blood Work- CRP
Description
C-Reactive protein (CRP)
Time Frame
Baseline and 4 weeks
Title
Blood Work- IL6
Description
Interleukin 6 (IL-6)
Time Frame
Baseline and 4 weeks
Title
Blood Work- TNFalpha
Description
TNF-alpha
Time Frame
Baseline and 4 weeks
Title
Questionnaires- Health Status
Description
Health research questionnaire; self reported medical and health history of participant.
Time Frame
Baseline
Title
Questionnaires- IPAQ
Description
International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.
Time Frame
Baseline and 8 weeks
Title
Questionnaires- SF36
Description
SF-36 Quality of Life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Questionnaires- MMSE
Description
Mini Mental State Examination (MMSE) 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Score is reported as 0-30 . 24-30 indicates no cognitive impairment, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment.
Time Frame
Baseline
Title
Questionnaires- FESI
Description
Falls Efficacy Scale-International; items are summed to calculate a range of total score from minimum 16 to maximum 64. The higher the score the greater the fear of falling.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Questionnaires- Nutrition
Description
Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.
Time Frame
Baseline
Title
Questionnaires- Charlson Comorbidity
Description
Charlson Comorbidity Index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality.
Time Frame
Baseline
Title
Questionnaires- BSCI
Description
Brief Screen for Cognitive Impairment (BSCI); Scores are weighted and summed to arrive at final score. Delayed recall and medication help each get a weight of 2.0, and errand help gets a weight of 1.0. If client does not take any medications, the weighted scores of the other two items perform similarly to the three-item version. Higher scores indicate greater frailty/cognitive impairment.
Time Frame
Baseline
Title
Questionnaires- Edmonton Frailty
Description
Edmonton Frailty Assessment; consists of nine domains and eleven items, each scoring 0 points (frailty absent or normal health), 1 point (minor errors or mild/moderate impairment), or 2 points (important errors or severely impaired). Higher scores indicate greater frailty.
Time Frame
Baseline
Title
Questionnaires- ECOG
Description
Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.
Time Frame
Baseline
Title
Questionnaires- Clock Test
Description
Clock Test; evaluates three items: "correctly drawn clock shape," "all numbers in the correct position," and "hands of the clock set to the correct time." A score of 1 was assigned for each of these items. Higher scores indicate greater frailty/cognitive impairment.
Time Frame
Baseline
Title
Accerlometry
Description
Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery.
Time Frame
Through study completion, an average of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients certified by a surgeon to participate in this study; Patients between the ages of 18 and 90; Patients with GI cancer. Exclusion Criteria: Patients with 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; Simultaneous participation in a pharmacotherapy trial; Estimated glomerular filtration rate (EGFR) < 30 and not currently on dialysis. Pregnant or lactating women Dementia Mini Mental State Examination score of Severe Impairment (≤17), or Patients with severe depression.
Facility Information:
Facility Name
Cardiovascular Aging Research Laboratory at UT Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be reported as average group means.
Citations:
PubMed Identifier
35608376
Citation
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.
Results Reference
derived

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

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