Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from Baseline Quality of Life (QoL) at 3 months
研究概览
简要总结
A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months. All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control. Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment
- •Taking an AI (aromatase inhibitors )，and had been receiving an AI for at least 6 months
排除标准
- •A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer
- •With exercise contraindications：chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse
- •Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months
- •Women reporting 5 hours or more of vigorous physical activity per week
研究组 & 干预措施
Exercise group
After completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week. The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China. Two senior Baduanjin teachers from Guangzhou Sports University conducted the training.
干预措施: Baduanjin exercise (Other)
Waiting list Control group
Participants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise.
After their post-assessment they were able to attend the Baduanjin classes.
干预措施: Baduanjin exercise (Other)
结局指标
主要结局
Change from Baseline Quality of Life (QoL) at 3 months
时间窗: at baseline and 3 months
European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)
次要结局
- Change from Baseline Symptoms of climacteric syndrome at 3 months(at baseline and 3 months)
- Change from Baseline Flexibility test at 3 months(at baseline and 3 months)
- Change from Baseline BMI at 3 months(at baseline and 3 months)
- Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months(at baseline and 3 months)
- Change from Baseline BMD at 3 months(at baseline and 3 months)
- Change from Baseline IL-1β at 3 months(at baseline and 3 months)
- Change from Baseline CRP at 3 months(at baseline and 3 months)
- Change from Baseline IL-6 at 3 months(at baseline and 3 months)
- Change from Baseline Fatigue at 3 months(at baseline and 3 months)
- Change from Baseline sleep quality at 3 months(at baseline and 3 months)
- Change from Baseline Aerobic Fitness Assessment at 3 months(at baseline and 3 months)
- Change from Baseline Muscle strength test at 3 months(at baseline and 3 months)
- Change from Baseline Balance test at 3 months(at baseline and 3 months)
- Change from Baseline TNF-α at 3 months(at baseline and 3 months)
研究者
KunWang
Professor
Guangdong Provincial People's Hospital