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临床试验/ChiCTR1800018171
ChiCTR1800018171已完成不适用

基于中医理论的系统康复运动在乳腺癌化疗患者中的应用

天津医科大学肿瘤医院1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Body mass index (BMI)

研究概览

简要总结

为促进化疗期乳腺癌患者的身心康复,改善生活质量,研究拟采用随机对照试验,对术后化疗期乳腺癌患者实施基于中医理论的系统康复运动指导,以有氧健身操、八段锦为主,辅以中医穴位按摩、健康讲座等多种形式的系统康复运动,即八段锦有氧组合运动,探讨其在改善患者身心状况,免疫功能(淋巴细胞亚群、IL-6、IL-1β)及生活质量等的效果,为促进化疗期乳腺癌患者的身心康复提供指导依据。

研究设计

研究类型
干预性研究
主要目的
随机平行对照
盲法
The group assignment of intervention group or control group was replaced by the English character A or B group, so that the research assistant who collected and entered study data remained blinded to group allocation throughout the study.

入排标准

年龄范围
36 至 72(—)
性别
Female

入选标准

  • ①在我院病理确诊为乳腺癌并行乳腺癌根治术者;②年龄≤75 岁;③无严重心肺疾患及影响运动的神经、肌肉、关节疾病者;④术后需要进行化疗的患者;⑤知情同意,自愿参加本研究。

排除标准

  • ①患者在研究期间中途退出;②既往有精神病史及严重认知功能障碍者;③锻炼参与率少于 80%者。

研究组 & 干预措施

Group 1

以有氧健身操、八段锦为主,辅以中医穴位按摩、健康讲座等多种形式的系统康复运动

Group 2

常规护理

结局指标

主要结局

Body mass index (BMI)

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Target heart rate

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Lung capacity

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Circumference of ill arm

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Shoulder mobility of ill arm

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Step test index

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Anxiety

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Depression

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

Quality of life

时间窗: At baseline before intervention and re-measured on the first week after finishing 6 month intervention period.

次要结局

未报告次要终点

研究者

发起方
天津医科大学肿瘤医院

研究点 (1)

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