Effects of Yoga on Physical Functioning and Sleep Quality of Women with Breast Cancer: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change from baseline Upper limb functional status at 4 weeks
研究概览
简要总结
Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer.
详细描述
Breast cancer is the most commonly diagnosed cancer worldwide, accounting for 12% of all new cancer cases annually, and there were an estimated 2.3 million new cases worldwide in 2020. Contemporary breast cancer treatments have improved therapeutic outcomes. However, these treatments cause adverse effects; for example, more than half of women with breast cancer experience treatment-related comorbidities.
Over 60% of women with breast cancer have reported experiencing ipsilateral upper limb complications immediately post-treatment and these complications may become chronic or permanent disorders. Upper limb dysfunction is a long-term complication that comprises a complex range of symptoms and disorders, including lymphedema, pain, decreased joint mobility and muscle strength, sensory alterations, and neuropathies. Another prevalent and persistent problem that has been reported is sleep disturbance. According to a recent review, the prevalence of sleep disturbance ranged from 14 to 90% [pooled estimated 0.4; 95% Confidence Interval (CI) 0.29 to 0.52], and the persistence rate has been found to be more than 50%. Such side effects may lead to individual suffering and economic burdens, and can compromise the quality of life of women with breast cancer. Thus, the management of treatment-related side effects is an important part of the supportive care of women with breast cancer.
Yoga is based on ancient India philosophy, and emphasizes the integration of postures, breathing, and meditation. This mind-body practice has gained popularity over the last decades and serves as a complementary approach that is commonly used for various health conditions. This safe and trendy exercise holds attractive to female target participants. Yoga combines joint movements and breathing exercises that can help the lungs to expand, resulting in the stretching of muscles and thus increasing lymphatic circulation, which improves upper limb function. Besides, Yoga combines physical activity with mindful elements consisting of breathing and meditative practices. The practice of such mindfulness with the engagement of skeletal muscles represents a holistic approach that may decrease sleep disturbance.
Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer. The research hypothesis of this study were (1) improvements in upper limb functions and sleep quality, could be observed in the experimental group across the assessment time points and (2) the experimental group should have better upper limb performance and sleep parameters than the control group immediately after Yoga intervention and also at the follow up.
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
After the baseline assessment, all eligible participants will be allocated randomly in a 1:1 ratio to either (1) experimental group which received yoga programme over a period of eight weeks, or (2) wait-list control group. The research assistant, who is responsible for allocation, is independent from the data collection and analysis, and the intervention. The participants will be reminded not to disclose information related to group allocation to the assessors to prevent possible bias during measurement. All assessments will be performed by an assessor who is blinded to the group allocation and not involved in the delivery of the intervention.
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
- •Normal cognitive function
- •Diagnosed with primary breast cancer of stage I-III
- •Completed cancer-related treatments (including surgery, radiotherapy, and/or chemotherapy) at least 4 weeks before enrollment except conventional medical care (e.g., hormonal therapy)
排除标准
- •Diagnosed with distant metastasis in non-breast body part
- •Diagnosed with significant diseases, such as cardiovascular, respiratory, neurological, musculoskeletal (except upper-extremity problems secondary to breast cancer), endocrine, metabolic, and psychological disorders
- •Being pregnant
- •Prior experiences of practicing yoga
结局指标
主要结局
Change from baseline Upper limb functional status at 4 weeks
时间窗: T2: mid-intervention (week 4)
Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability
Upper limb functional status, score range 0-100%, higher score means more severe disability
时间窗: T1: baseline (before the study begins).
Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH)
Change from baseline Upper limb functional status at 8 weeks
时间窗: T3: immediately post-intervention (week 8)
Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability
Sleep quality
时间窗: T1: baseline (before the study begins)
Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep
Change from baseline Sleep quality at 8 weeks
时间窗: T3: immediately post intervention (week 8)
Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep
Change from baseline Sleep quality at 12 weeks
时间窗: T4: 1 month follow up (week 12)
Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep
Change from baseline Sleep quality at 4 weeks
时间窗: T2: mid-intervention (week 4)
Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep
Change from baseline Upper limb functional status at 12 weeks
时间窗: T4: 1 month follow up (week 12)
Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability
次要结局
- Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks(T2: mid-intervention (week 4))
- Change from baseline Upper limb muscle strength at 8 weeks(T3: immediately post intervention (week 8))
- Change from baseline Shoulder mobility at 4 weeks(T2: mid-intervention (week 4))
- Change from baseline Shoulder mobility at 12 weeks(T4: 1 month follow up (week 12))
- Mood (including anxiety and depression symptoms)(T1: baseline (before the study begins))
- Upper limb muscle strength(T1: baseline (before the study begins))
- Change from baseline Upper limb muscle strength at 12 weeks(T4: 1 month follow up (week 12))
- Shoulder mobility(T1: baseline (before the study begins))
- Change from baseline Shoulder mobility at 8 weeks(T3: immediately post intervention (week 8))
- Fatigue(T1: baseline (before the study begins))
- Change from baseline Fatigue at 12 weeks(T4: 1 month follow up (week 12))
- Health-related quality of Life(T1: baseline (before the study begins))
- Change from baseline Upper limb muscle strength at 4 weeks(T2: mid-intervention (week 4))
- Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks(T3: immediately post intervention (week 8))
- Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks(T4: 1 month follow up (week 12))
- Change from baseline Fatigue at 4 weeks(T2: mid-intervention (week 4))
- Change from baseline Fatigue at 8 weeks(T3: mid-intervention (week 8))
- Change from baseline Heart rate variability at 4 weeks(T2: mid-intervention (week 4))
- Heart rate variability(T1: baseline (before the study begins))
- Change from baseline Heart rate variability at 8 weeks(T3: immediately post intervention (week 8))
- Change from baseline Health-related quality of Life at 12 weeks(T4: 1 month follow up (week 12))
- Change from baseline Heart rate variability at 12 weeks(T4: 1 month follow up (week 12))
- Change from baseline Health-related quality of Life at 4 weeks(T2: mid-intervention (week 4))
- Change from baseline Health-related quality of Life at 8 weeks(T3: immediately post intervention (week 8))
研究者
Shamay Ng
Professor
The Hong Kong Polytechnic University