Tai-Chi Exercise Reduces Fatigue in Breast Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Reduced Fatigue
研究概览
简要总结
Tai-Chi Exercise Reduces Fatigue in Breast Cancer Patients Undergoing Chemotherapy.
The main question it aims to answer is: Does Tai-chi training reduce fatigue in breast cancer patients? Participants performed the exercise on the day agreed upon with the researcher. All participants were given routine care, and leaflets related to chemotherapy, psychological aspects of cancer patients, nutrition, and management of cancer symptoms. While respondents in the intervention group received 5 times Tai-Chi practice interventions in a week for 3 weeks with a duration of 30 minutes of each practice, using 18 forms of Tai-Chi shibashi adapted from Yang's style. Before the Tai-Chi intervention is implemented, standard training was given once to each respondent by an experienced Tai-Chi master, as well as video tutorials for independent practice at home demonstrated by the Tai-Chi master.
During the three weeks of practicing Tai-Chi at home, each respondent was asked to fill out a logbook for each exercise, and fill out a fatigue questionnaire every three days, while the control group was asked to fill out their daily physical activities reports on the logbook. The researcher invited the intervention group respondents to the WhatsApp Group to remind the participants to practice the Tai-Chi exercise at home every day, evaluate side effects during exercise and fill out a fatigue questionnaire in the logbook. The researcher also invited control group respondents to the WhatsApp Group to remind participants to fill in their daily physical activities and fill out fatigue questionnaires in the logbook.
Research respondents who met the inclusion criteria were randomized by research assistants using block randomization with sorted random tables, the order of randomization was kept by research assistants who were not directly involved in the study. After the respondents who met the requirements were identified and completed the pre-test, the researcher contacted the research assistant to place the respondents in the intervention or control group according to a pre-determined randomization sequence. Due to the observable nature of Tai-Chi practice, the lack of a sham comparison group, and the pre-test and post-test measurements reported by the respondents, blindness could not be performed on the respondents. Data collection and follow-up is carried out every 3 days via chat or telephone. Based on the initial sample count, there were 23 respondents in each group (n = 46), and to cover the possibility of 25% drop-out respondents, the correction for the sample size of this study was 61 respondents, 31 respondents in the intervention group, 30 respondents in the control.
详细描述
The research process was guided by the CONSORT Statement for RCTs. The process involved registration, allocation, follow-up, and analysis. The recruitment process began with a feasibility assessment for potential respondents. This process was carried out when the patient conducted a phase 2 rehabilitation evaluation. Researchers initially reviewed patient data through medical records, reviewing ID, color code, age, gender, medical history, patient condition, and location of residence. Patients' communication skills were assessed during the evaluation.
This study used a randomized clinical trial design with a pre-post-test with control group approach. The inclusion criteria for the study sample were conscious and cooperative patients (compos mentis), patients with a good condition, breast cancer patients undergoing chemotherapy, aged 18-64 years, stage 0-III, having an electronic cell phone or laptop, and willing to participate. The exclusion criteria in this study were patients with mental illness or severe cognitive impairment.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the study sample were conscious and cooperative patients (compos mentis), patients with a good condition, breast cancer patients undergoing chemotherapy, aged 18-64 years, stage 0-III, having an electronic cell phone or laptop, and willing to participate.
排除标准
- •The exclusion criteria in this study were patients with mental illness or severe cognitive impairment.
研究组 & 干预措施
Intervention Group
Performed Tai-Chi
干预措施: Tai-chi (Behavioral)
Control Group
Performed Daily Physical Activities
干预措施: Daily Physical Activities (Behavioral)
结局指标
主要结局
Reduced Fatigue
时间窗: 3 Weeks
Reduced Fatigue Scores
次要结局
未报告次要终点
研究者
Chairul Huda
Ns. Chairul Huda, S.Kep., M.Kep., Sp.Kep.M.B
Indonesia University