Feasibility and Preliminary Evaluation of an Evidence-based Baduanjin Exercise Program for Upper Limb Dysfunction in Breast Cancer Survivors: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Upper Limb Dysfunction
研究概览
简要总结
The goal of this clinical trial is to learn if Baduanjin exercise could be adopted by breast cancer survivors and improve their upper limb dysfunction. The main questions it aims to answer are:
- Does Baduanjin exercise improve upper limb dysfunction among breast cancer survivors?
- What problems or adverse events do participants have if they adopt Baduanjin exercise to improve upper limb dysfunction?
Participants will:
- Adopt Baduanjin exercise following an evidence-based intervention protocol
- Report their exercise frequency, length, and unexpected symptoms
- Receive three times assessment and follow-up every week
详细描述
To evaluate the feasibility, acceptability, and preliminary effects of Baduanjin exercise on upper limb dysfunction (ULD), shoulder range of motion (ROM), pain, sleep quality, depression and anxiety, and quality of life (QoL) in breast cancer survivors. The objectives of this study are to:
- Develop an evidence-based Badunajin exercise intervention protocol for managing ULD among breast cancer survivors ;
- Design and conduct a pilot Randomised Controlled Trial (RCT) using the Buduanjin exercise intervention protocol to manage the ULD;
- Test the feasibility and acceptability of the Baduanjin exercise intervention and RCT procedures by the recruitment rate, retention rate, and attrition rate during the pilot RCT;
- Evaluate the safety, efficacy, and acceptability of the Baduanjin exercise intervention by identifying potential adverse effects associated with the Baduanjin exercise intervention;
- Examine the potential effects of Baduanjin exercise intervention on ULD, shoulder ROM, pain, sleep quality, depression and anxiety, as well as QoL among breast cancer survivors;
- Explore the participants' experience and suggestions for the Baduanjin exercise intervention and study procedures; and
- Provide evidence for refinement of the Baduanjin exercise intervention for a multi-center, full-scale RCT among breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥ 18 years, diagnosed with non-metastatic unilateral Stage I-IIIa non-metastatic breast cancer, regardless of cancer type;
- •Surgeries completed at least two months before enrolment, and completion of radiotherapy and/or chemotherapy, with or without aromatase inhibitor therapy, upon enrolment;
- •Experiencing breast cancer treatment-related ULD, which is measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) scale with a score of 20 or above;
- •Karnofsky Performance Status Scale (KPS), used to measure a patient's ability to perform daily activities and self-care independently, with a score of 90 or above;
- •Ability to read, write, and communicate in Chinese;
- •Have a personal cellphone;
- •Agree to participate in this study and provide written informed consent.
排除标准
- •Any patient with a history of upper limb surgery, injury (fracture or shoulder dislocation), or other conditions not related to breast cancer treatments;
- •With other complications or adverse medical conditions that cannot perform BdjE, such as severe lymphedema, axillary web syndrome, or adhesive capsulitis;
- •Undergoing any physiotherapy for ULD or leading regular physical exercises in the previous three months;
- •Had skin grafting and autologous myocutaneous flap breast reconstruction;
- •Current clinical diagnosis of depression or anxiety, or receipt of active psychological treatment for significant mood or anxiety disorders;
- •Currently involved in other clinical studies.
研究组 & 干预措施
Control arm
Participants in this arm will take their routine activity.
Baduanjin arm
Participants in this arm will adopte Baduanjin exercise following the intervention protocol
干预措施: Baduanjin exercise (Behavioral)
结局指标
主要结局
Upper Limb Dysfunction
时间窗: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
The Disability of Arm, Shoulder, and Hand (DASH) (Chinese version) will assess upper limb dysfunction. The DASH has 30 items, and 5-Likert scale was used to demonstrate the disability of the upper limb (1=not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely), and DASH symptom score = \[(sum of n response)/n-1\] \*25 (n is the number of completed responses)(Hudak et al., 1996). A higher score indicates a greater disability. At least 27 items must be completed for each questionnaire, or it will not be able to calculate a score.
次要结局
- Quality of Life(QoL)(At enrollment, at the end of the intervention, and eight weeks after the intervention completion)
- Shoulder Range of Motion (ROM)(At enrollment, at the end of the intervention, and eight weeks after the intervention completion)
- Pain(At enrollment, at the end of the intervention, and eight weeks after the intervention completion)
- Sleep Quality(At enrollment, at the end of the intervention, and eight weeks after the intervention completion)
- Depression and Anxiety(At enrollment, at the end of the intervention, and eight weeks after the intervention completion)
研究者
Jinqiu Li
Principal Investigator
University of Southern Queensland