Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Hospital Measures- Length of hospital stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients certified by a surgeon to participate in this study;
- •Patients between the ages of 18 and 90;
- •Patients with GI cancer.
排除标准
- •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
- •Mini Mental State Examination score of Severe Impairment (≤17), or
- •Patients with severe depression.
结局指标
主要结局
Hospital Measures- Length of hospital stay
时间窗: Through study completion, an average 1year
Length of hospital stay
Hospital Measures- Readmission
时间窗: Through study completion, an average 1 year
Readmission
Hospital Measures
时间窗: Through study completion, an average 1 year
Mortality
Hospital Measures- Emergency room visits
时间窗: Through study completion, an average 1 year
emergency room visits
次要结局
- Physical Fitness- TUG(Baseline, 4 weeks, and 8 weeks)
- Blood Work- CRP(Baseline and 4 weeks)
- Physical Fitness- 6MWT(Baseline and 4 weeks)
- Accerlometry(Through study completion, an average of one year)
- Physical Fitness- SPPB(Baseline and 4 weeks)
- Questionnaires- SF36(Baseline, 4 weeks, and 8 weeks)
- Questionnaires- FESI(Baseline, 4 weeks, and 8 weeks)
- Questionnaires- BSCI(Baseline)
- Physical Fitness- Hand Grip(Baseline, 4 weeks, and 8 weeks)
- Blood Work- AA(Baseline and 4 weeks)
- Blood Work- TNFalpha(Baseline and 4 weeks)
- Questionnaires- Health Status(Baseline)
- Questionnaires- ECOG(Baseline)
- Body Composition(Baseline and 4 weeks)
- Blood Work- IL6(Baseline and 4 weeks)
- Questionnaires- MMSE(Baseline)
- Questionnaires- Clock Test(Baseline)
- Questionnaires- IPAQ(Baseline and 8 weeks)
- Questionnaires- Nutrition(Baseline)
- Questionnaires- Charlson Comorbidity(Baseline)
- Questionnaires- Edmonton Frailty(Baseline)
研究者
Hirofumi Tanaka
Professor
University of Texas at Austin