Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Peak oxygen comsumption
研究概览
简要总结
Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment
All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.
The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.
This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board
详细描述
Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 to 70 years
- •Confirmed diagnosis of gastric, hepatic, colon or rectal cancer.
- •Live in Bogota for at least 3 months
- •Hemoglobin concentration superior to 10g/dL
- •Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment
- •ECOG score 0 or 1
排除标准
- •Behavior or cognitive impairment
- •musculoskeletal impairment
- •any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis)
- •Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia)
- •Presence of obstructive or restrictive pulmonary disease
- •Enrolled in another supervised exercise program
- •Major electrocardiographic abnormalities.
研究组 & 干预措施
Preoperative exercise program
The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks.
Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows:
Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.
干预措施: Preoperative exercise program (Other)
结局指标
主要结局
Peak oxygen comsumption
时间窗: 4 weeks after the exercise program beginning
peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
次要结局
- program adherence(3 weeks after the exercise program beginning.)
- Peak oxygen comsumption - 3 weeks(3 weeks after the exercise program beginning)
- exercise-related adverse events(3 and 4 weeks after the exercise program beginning)