An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- QoL(quality of life)
研究概览
简要总结
Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early gastric cancer patients
- •Undergoing minimally invasive surgery
- •A patient who did not exercise regularly for the last 6 months
- •A patient who signed the informed consent
排除标准
- •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
研究组 & 干预措施
Exercise group
physical activity intervention
干预措施: physical activity intervention (Behavioral)
Control group
结局指标
主要结局
QoL(quality of life)
时间窗: 10 weeks after gastrectomy
次要结局
- cardiopulmonary function test(10 weeks after gastrectomy)
- vital signs reflecting of inflammation level(10 weeks after gastrectomy)
- nutrition condition(10 weeks after gastrectomy)