The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Physical Function
研究概览
简要总结
This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.
详细描述
Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life.
The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients
- •Age greater than or equal to 18 years old
- •Have a tendency to be admitted to the ICU after the surgery
- •Fill the eligible criteria to start enteral feeding within 72 hours
- •Sign the consent form;
排除标准
- •Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) >60% or positive end expiratory pressure (PEEP) > 12cm H2O
- •Bronchopleural fistula
- •Karnofsky <50
- •Participant cannot b enrolled in another study
研究组 & 干预措施
High-protein diet
High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
干预措施: Intervention (Dietary Supplement)
Normoproteic diet
Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Physical Function
时间窗: 8 days after randomization
6 minutes walk test
次要结局
- Physical Function(30 days after randomization)
- Quality of life(6 months after randomization)
- Body Composition related to prognosis(8 days after randomization)
- Postoperative complications(30 days after randomization)
- Resting Energy Expenditure(one day before surgery and one day after surgery)
- Length of hospital stay.(30 days after randomization)
研究者
Juliano P Almeida, MD, PhD
Medical Doctor
University of Sao Paulo