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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04073381
Other study ID # 2018-08-0110
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 28, 2018
Est. completion date August 31, 2020

Study information

Verified date July 2021
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date August 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Prehabilitation Program
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)

Locations

Country Name City State
United States Cardiovascular Aging Research Laboratory at UT Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Measures- Length of hospital stay Length of hospital stay Through study completion, an average 1year
Primary Hospital Measures- Emergency room visits emergency room visits Through study completion, an average 1 year
Primary Hospital Measures- Readmission Readmission Through study completion, an average 1 year
Primary Hospital Measures Mortality Through study completion, an average 1 year
Secondary Physical Fitness- Hand Grip Hand grip dynamometry Baseline, 4 weeks, and 8 weeks
Secondary Physical Fitness- 6MWT 6 minute walk test Baseline and 4 weeks
Secondary Physical Fitness- TUG Timed up and go Baseline, 4 weeks, and 8 weeks
Secondary Physical Fitness- SPPB Short Physical Performance Battery Assessing Lower Extremity Function Baseline and 4 weeks
Secondary Body Composition DXA (dual energy X-ray absorptiometry) will be used to assess body composition. Baseline and 4 weeks
Secondary Blood Work- AA Amino Acids Baseline and 4 weeks
Secondary Blood Work- CRP C-Reactive protein (CRP) Baseline and 4 weeks
Secondary Blood Work- IL6 Interleukin 6 (IL-6) Baseline and 4 weeks
Secondary Blood Work- TNFalpha TNF-alpha Baseline and 4 weeks
Secondary Questionnaires- Health Status Health research questionnaire; self reported medical and health history of participant. Baseline
Secondary Questionnaires- IPAQ International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days. Baseline and 8 weeks
Secondary 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. Baseline, 4 weeks, and 8 weeks
Secondary 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. Baseline
Secondary 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. Baseline, 4 weeks, and 8 weeks
Secondary Questionnaires- Nutrition Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend. Baseline
Secondary 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. Baseline
Secondary 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. Baseline
Secondary 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. Baseline
Secondary Questionnaires- ECOG Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy. Baseline
Secondary 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. Baseline
Secondary Accerlometry Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery. Through study completion, an average of one year
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