Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Protein Synthesis
研究概览
简要总结
The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.
详细描述
Intervention Physical exercise program
At the baseline assessment all patients' physical fitness will be evaluated by the kinesiologist (exercise specialist). The exercise component will consist of approximately 60 min of resistance and aerobic training, for a minimum of 3 days per week. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard)50 and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 % of heart rate reserve, HRR), and 25 min of resistance training (8 exercises targeting major muscle groups performed at moderate intensity), and a 5-10 min cool-down and stretching period. All exercises will be clearly explained and demonstrated by the kinesiologist at baseline. Patients will be asked to carry out this program at home, unsupervised, but will be monitored with weekly telephone calls. Training intensity progression will occur when the participant can complete aerobic exercise on mild exertion and/or when the participant can complete 15 repetitions of a given resistance exercise. Participants will be provided with resistance bands and an exercise mat, as well as a pedometer and a heart rate monitor, which can be used by the participant to monitor progress and by the kinesiologist to monitor daily compliance. A log book will also be completed to report all activities and frequency of exercises completed.
The kinesiologist will follow (by telephone call) all the participants on a weekly basis to ensure program compliance and address any barriers that may prevent ongoing participation.
Nutritional counseling The patients' nutritional status and adequacy of dietary intake will be assessed by a nutritionist using a three day food record, biological indices (e.g. glycated hemoglobin), clinical history, and the Patient-Generated Subjective Global Assessment tool51. Anthropometric measures, including percentage of lean body mass and fat, will be measured with bioelectrical impedance and skin calipers. Nutritional care plans will focus on meeting daily protein requirements (1.2g/kg), management of cancer-related symptoms (such as diarrhea, constipation), blood glucose control, optimization of body composition (i.e. weight loss/gain if necessary) and nutrient intake through providing practical suggestions, based on actual intake, to improve macronutrient distributions of protein, fat, and carbohydrates.
The type of dietary protein (amino acid composition), digestibility, amount, timing of intake, and co-ingestion with other macronutrients can be used to capitalize on post-exercise induced muscle protein synthesis52. Twenty (20) grams of protein, in liquid form, taken immediately after resistance exercise is regarded as sufficient to maximally stimulate muscle protein synthesis in healthy individuals52. Whey protein, in particular, is regarded as being especially effective when ingested after exercise54 because it is rapidly digested and contains all of the indispensable amino acids including leucine, which is believed to independently stimulate translation initiation of protein synthesis in skeletal muscle52. Post exercise co-ingestion with carbohydrate does not appear to provide any further anabolic effect, although does improve protein balance by blunting proteolysis and maximally stimulating insulin secretion55.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective colorectal surgery for cancer
- •65 years and older
排除标准
- •American Society of Anesthesiologists (ASA) health status class 4-5
- •disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
- •endocrine disorders (diabetes or hemoglobin A1C>6, hyper and hypothyrodisim)
- •steroid consumption
- •cardiac failure (New York Heart Association classes I-IV)
- •chronic obstructive pulmonary disease
- •renal failure (creatinine > 115µmol/l)
- •hepatic failure (liver aminotranferases >50% the normal range)
- •morbid obesity (BMI >40)
- •anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
- •poor comprehension of English or French
研究组 & 干预措施
Prehabilitation
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
干预措施: whey protein supplementation (Dietary Supplement)
Prehabilitation
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
干预措施: Prehabilitation (Other)
Prehabilitation
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
干预措施: hyperinsulinemic euglycemic isoaminoacid clamp (Device)
Prehabilitation
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
干预措施: hyperinsulinemic euglycemic hyperaminoacid clamp (Device)
结局指标
主要结局
Protein Synthesis
时间窗: up to 4 weeks before surgery
The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
次要结局
未报告次要终点
研究者
Franco Carli
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre
