This Trial Corresponds to the Manuscript Titled: Effects of Tai Chi on Balance and Sleep Quality in Colorectal Cancer Patients Undergoing Chemotherapy
Effect of Tai Chi Exercise Intervention on Physical and Mental Distress of Patients With Colorectal Cancer During Adjuvant Chemotherapy
Colorectal cancer patients receiving adjuvant chemotherapy may experience reduced physical fitness, fatigue, emotional distress, sleep problems, and impaired quality of life. This study evaluated whether a 24-week Tai Chi exercise program could improve physical and psychological outcomes in patients with colorectal cancer undergoing adjuvant chemotherapy.
Participants were randomly assigned to either a Tai Chi exercise group or a usual-care control group. Participants in the Tai Chi group were instructed to perform at least 150 minutes of Tai Chi exercise per week for 24 weeks, while participants in the control group received usual care. Physical fitness, fatigue, depression, anxiety, sleep quality, and quality of life were assessed during the study.
研究概览
详细说明
This study used a randomized, two-group, repeated-measures design to evaluate the effects of a 24-week Tai Chi exercise program in patients with colorectal cancer undergoing adjuvant chemotherapy.
Eligible participants were adults aged 20 years or older who had undergone colorectal cancer surgery for the first time and were scheduled to receive six months of adjuvant chemotherapy. Participants were randomly assigned to the Tai Chi exercise group or the usual-care control group using a computer-generated random-number procedure.
Participants assigned to the intervention group received usual care and participated in a 24-week Tai Chi exercise program. They were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to the participant's physical condition and treatment schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address difficulties encountered during exercise.
Participants assigned to the control group received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.
Study outcomes included upper- and lower-extremity muscle strength, static and dynamic balance, fatigue, depression, anxiety, sleep quality, and quality of life. Assessments were conducted before the first adjuvant chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment.
A total of 60 participants were enrolled, including 31 participants assigned to the Tai Chi exercise group and 29 assigned to the usual-care control group. Fifty-three participants completed the study assessments.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Taiwan
-
New Taipei City、Taiwan、台湾、251020
- Tamsui Mackay Memorial Hospital
-
Taipei、Taiwan、台湾、104217
- Mackay Memorial Hospital
-
-
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:
- Aged 20 years or older
- Underwent colorectal cancer surgery for the first time
- Scheduled to receive six months of adjuvant chemotherapy following colorectal cancer surgery
- No other serious medical condition
- No acute functional decline during hospitalization
- Willing to participate and able to provide written informed consent after receiving an explanation of the study
- Able to communicate in Mandarin Chinese or Taiwanese
- Clinically stable and receiving regular outpatient follow-up
Exclusion Criteria:
- Required radiotherapy or targeted therapy in addition to adjuvant chemotherapy after surgery
- Admitted to an intensive care unit because of trauma surgery, heart failure, end-stage disease, or another serious condition
- Valvular heart disease, atrial fibrillation, cardiomyopathy, myocarditis, uncontrolled chronic disease, or congestive heart failure
- Unable to clearly communicate level of consciousness, symptoms, or feelings
- Severe visual or hearing impairment
- Diagnosed psychiatric disorder
- Medically advised not to exercise
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Tai Chi Exercise Group
Participants received usual care and completed a 24-week Tai Chi exercise program, with a target of at least 150 minutes of Tai Chi exercise per week. |
A 24-week home-based Tai Chi exercise program consisting of slow, low-impact movements, warm-up exercises, muscle-strengthening movements, and cool-down exercises. Participants were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to each participant's physical condition and chemotherapy schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address exercise-related difficulties. |
|
无干预:Usual Care Control Group
Participants received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Fatigue was assessed using the Brief Fatigue Inventory-Taiwan Form. The instrument contains three items assessing fatigue severity and six items assessing interference of fatigue with daily functioning. Each item is rated from 0 to 10, with higher scores indicating greater fatigue severity or interference. Mean fatigue severity and fatigue interference scores were calculated. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Grip Strength
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Upper-extremity muscle strength was assessed using a Camry EH101 electronic handgrip dynamometer. Participants performed the test three times with their dominant hand while standing with their arms naturally positioned at their sides. A rest period of 1 to 2 minutes was provided between measurements. The highest value from the three measurements was recorded in kilograms. Higher values indicate greater grip strength. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Lower-Extremity Muscle Strength Measured by the 30-Second Chair Stand Test
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Lower-extremity muscle strength and endurance were assessed using the 30-Second Chair Stand Test. Participants began seated in a 0.43-meter-high chair with their arms crossed over their chest and were instructed to rise to a full standing position and return to a seated position as many times as possible within 30 seconds. The total number of correctly completed stands was recorded. Higher numbers indicate better lower-extremity muscle strength and endurance. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Depression Severity Measured by the Beck Depression Inventory-II
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Depressive symptoms were assessed using the Chinese version of the Beck Depression Inventory-II (BDI-II). The instrument contains 21 items assessing cognitive, affective, and somatic symptoms of depression. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Anxiety Severity Measured by the Beck Anxiety Inventory
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Anxiety symptoms were assessed using the Chinese version of the Beck Anxiety Inventory (BAI). The instrument contains 21 items assessing subjective anxiety, panic-related symptoms, and somatic symptoms of anxiety. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The instrument contains 19 self-rated items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, producing a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Health-Related Quality of Life Measured by the EORTC QLQ-C30
大体时间:Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Health-related quality of life was assessed using the Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 30-item instrument includes five functional scales, three symptom scales, six single-item symptom measures, and a global health status/quality-of-life scale. Scale scores range from 0 to 100. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales and single-item measures indicate greater symptom burden. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
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 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 20MMHIS382e
- 20MMHIS382e (其他标识符:Mackay Memorial Hospital Institutional Review Board approval number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Individual participant data will not be shared because the informed consent obtained from participants did not include authorization for public or external sharing of individual-level data. Data sharing is also restricted to protect participant privacy and confidentiality in accordance with the approved study protocol and institutional review board requirements.
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研究美国 FDA 监管的设备产品
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