Effects of Physical Activity Based on the Transtheoretical Model on Patients With Endometrial Cancer Undergoing Fertility-sparing Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants were patients who met the following predefined eligibility criteria: Ages 20-40; Overweight or obese; The pathological diagnosis was EC (endometrioid, grade I, no myometrium invasion or metastasis). Not pregnant; Be willing to comply with test requirements after being fully informed of all risks and inconveniences associated with the test.
排除标准
- •Recurrent or metastatic disease; Currently participating in regular exercise at least 2 days per week; Pregnant at the start of the study; Or unwilling to comply with research requirements. Patients also completed the Physical Activity Readiness Questionnaire (PAR-Q) through a telephone interview. Patients with one or more potential exercise-related safety risks were excluded.
研究组 & 干预措施
control group
Maintain the current state of physical activity, do not do physical activity intervention.
Physical activity group
Exercise intervention According to the guidelines of the American Sports Medicine Association (ACSM) and the National Fitness guidelines of the General Administration of Sport of China
干预措施: Physical activity (Behavioral)
结局指标
主要结局
Body weight
时间窗: Enrollment，four months after the intervention
Body weight measured naked or wearing work clothes of known weight, an electronic weight scale is used to measure
BMI
时间窗: Enrollment，four months after the intervention
Body mass index is a standard commonly used in the world to measure the degree of body fat and whether it is healthy. The formula is BMI= weight ÷ height\*height
physical activity level
时间窗: Enrollment，four months after the intervention
Physical activity energy was calculated using the formula of the International Physical Activity Questionnaire. Calculation Manual: Physical activity amount (MEt-minutes /week)= physical activity intensity MET value × physical activity time (minutes)/ day × activity days.
次要结局
- triglyceride(Enrollment，four months after the intervention)
- serum total cholesterol(Enrollment，four months after the intervention)
- Waist Hip Ratio(Enrollment，four months after the intervention)
研究者
Xiaodan Li
associate professor
Peking University People's Hospital