Randomised Controlled Trial of Qigong Training Programme to Alleviate Arm Oedema, ¬Reduce Shoulder Impairment, Improve Body Balance and Quality of Life in Community-dwelling Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in arterial resistance and blood flow velocities
研究概览
简要总结
Objectives: (1) To investigate the effects of Qigong training on upper limb oedema, circulatory status, shoulder flexibility and muscular strength, body balance, and quality of life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship between the impairment outcomes and QOL outcomes.
Hypothesis: (1) The experimental participants will have less impairment and a better QOL after Qigong training compared with the no-training control group; and (2) the impairment parameters will be related to the QOL indexes in the Qigong participants.
Design and subjects: This will be a prospective, randomised, single-blinded controlled trial. Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong training group (n~30) or control group (n~30).
Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal Qigong training for 3 months with two supervised 1-hour sessions per week.
Main outcome measures: The primary outcome measures are upper limb circumference, arterial blood flow velocities and resistance index, shoulder joint passive range of motion, muscular strength (peak force) and body balance. The secondary outcome measure is quality of life as measured by the Functional Assessment of Cancer Therapy - Breast scale.
Data analysis: Data will be analysed via repeated-measures analysis of variance followed by post-hoc tests (α = 0.05).
Expected results: The investigators pilot studies produced encouraging results on the efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors. Therefore, the investigators expect that participants in the Qigong group will have fewer upper limb impairments and a better quality of life after Qigong training. If the results are positive, this Qigong training regime is readily transferrable to clinical practice, and could have positive socioeconomic effects such as reduced healthcare costs.
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)
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
- •The inclusion criteria are
- •history of a breast malignancy of any stage
- •history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
- •having completed conventional cancer treatment and medically stable
- •no known neurological deficits resulting from breast cancer treatment or other neurological disorders
- •persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
- •female aged 18 or above.
排除标准
- •The exclusion criteria are
- •presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder
- •receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
- •recurrent cancer or cancer that has spread to another organ
- •participation in regular physical activity
- •prior experience of Qigong or Tai Chi
- •a smoking habit
- •pregnancy during the study period.
结局指标
主要结局
Change in arterial resistance and blood flow velocities
时间窗: Baseline (0 month) and post-intervention (3 months)
A Doppler ultrasound machine will be used to examine the arterial blood flow velocities.
Change in body balance
时间窗: Baseline (0 month) and post-intervention (3 months)
Standing balance of the participants will be measured using timed single leg standing test.
Change in upper limb circumference
时间窗: Baseline (0 month) and post-intervention (3 months)
Circumference of both arms will be measured using a cloth measuring tape.
Change in shoulder muscular strength
时间窗: Baseline (0 month) and post-intervention (3 months)
The maximum isometric muscular strength of the shoulder flexor, abductor, internal rotator and external rotator muscles will be measured bilaterally using the Lafayette Manual Muscle Test System.
Change in shoulder flexibility
时间窗: Baseline (0 month) and post-intervention (3 months)
A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction.
次要结局
- Change in quality of life(Baseline (0 month) and post-intervention (3 months))
研究者
Shirley S.M. Fong
Assistant Professor, DRPC chairperson
The University of Hong Kong