Cardiovascular Aging Research Laboratory at UT Austin
Austin, Texas, 78712, United States
NCT Number: NCT04073381
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.
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Notify Me18 year–90 year
All sexes
Interventional
Early Phase 1
Austin, Texas, 78712, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with
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)
Time frame: Through study completion, an average 1year
Length of hospital stay
Time frame: Through study completion, an average 1 year
emergency room visits
Time frame: Through study completion, an average 1 year
Readmission
Time frame: Through study completion, an average 1 year
Mortality
Time frame: Baseline, 4 weeks, and 8 weeks
Hand grip dynamometry
Time frame: Baseline and 4 weeks
6 minute walk test
Time frame: Baseline, 4 weeks, and 8 weeks
Timed up and go
Time frame: Baseline and 4 weeks
Short Physical Performance Battery Assessing Lower Extremity Function
Time frame: Baseline and 4 weeks
DXA (dual energy X-ray absorptiometry) will be used to assess body composition.
Time frame: Baseline and 4 weeks
Amino Acids
Time frame: Baseline and 4 weeks
C-Reactive protein (CRP)
Time frame: Baseline and 4 weeks
Interleukin 6 (IL-6)
Time frame: Baseline and 4 weeks
TNF-alpha
Time frame: Baseline
Health research questionnaire; self reported medical and health history of participant.
Time frame: Baseline and 8 weeks
International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.
Time frame: Baseline, 4 weeks, and 8 weeks
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
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, 4 weeks, and 8 weeks
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
Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.
Time frame: Baseline
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
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
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
Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.
Time frame: Baseline
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: Through study completion, an average of one year
Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery.
University of Texas at Austin
Other
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