An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial (Gastric cancer)
研究概览
详细说明
There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.
However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients.
Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. Thus, the investigators have done the pilot study about how to practice the exercise program and how to evaluate the effect on the recovery. Based on the result of pilot study which could identify the safety and the feasibility , the investigators would like to do a prospective randomized controlled study to prove the effect of exercise program after surgery
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Seoul、大韩民国、134
- Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Early gastric cancer patients
- Undergoing minimally invasive surgery
- AGE: 20-70
- ECOG: 0-1
- A patient who did not exercise regularly for the last 6 months
- A patient who signed the informed consent
Exclusion Criteria:
- Pregnancy or plans to become pregnant
- Cognitive disabilities
- Other primary cancer history
- History of major abdominal surgery except current surgery
- Cardiopulmonary medical comorbidity
- Living > 60 km from the hospital
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制组
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实验性的:Exercise group
physical activity intervention
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Exercise program is scheduled to be conducted in three phases.
Phase I is in-hospital exercise program.
This program will be conducted in hospital during 1 week after surgery.
Phase II is home-exercise program that will be performed at home during 1 week after discharge.
Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program.
Main-exercise program is focused on the functional recovery.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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QoL(quality of life)
大体时间:10 weeks after gastrectomy
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10 weeks after gastrectomy
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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cardiopulmonary function test
大体时间:10 weeks after gastrectomy
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10 weeks after gastrectomy
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vital signs reflecting of inflammation level
大体时间:10 weeks after gastrectomy
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10 weeks after gastrectomy
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nutrition condition
大体时间:10 weeks after gastrectomy
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10 weeks after gastrectomy
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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