Qigong for Pre-frail and Frail Older Cancer Survivors: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Feasibility: Study completion rate
研究概览
简要总结
To-date, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.
详细描述
Frailty is an emerging concept in geriatric research and practice. It is defined as a state of increased vulnerability to adverse outcomes including death. A cohort study has found that respondents with cancer were significantly more frail compared to those without cancer. A plausible explanation is both cancer itself and the therapies used to treat it add additional stressors that challenge a patient's physiologic reserve. A systematic review has revealed a high prevalence of frailty and pre-frailty in older cancer patients, with the median estimates of 42% and 43%, respectively. Cancer treatment can hasten survivors' aging process and increase their risk of developing frailty, thus placing cancer survivors at heightened risk of such poor health outcomes as falls, fractures, and disability. This calls for effective interventions that would improve frailty in older cancer survivors.
Qigong, a type of mind-body intervention, is particularly suitable for older adults, as it is implemented without aerobic and musculoskeletal strain. This equipment-free form of exercise is ideal for settings with limited resources, as well as for the frail elderly, because it can be performed at home at any time, reducing such barriers as weather, transportation, and cost. Meta-analysis suggests that Baduanjin is beneficial in the general population in terms of improved quality of life, balance, handgrip strength, and trunk flexibility. To our knowledge, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is therefore to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly 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
- Single (Outcomes Assessor)
盲法说明
The care providers, though cannot be blinded, will not have knowledge about the aims of the study. The research assistants responsible for assessing the outcomes and entering the data will be blinded to the group.
allocation.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with stage I-III non-metastatic cancer
- •completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
- •classified as pre-frail or frail based on Fried frailty criteria
- •can communicate in Cantonese or Putonghua
- •written informed consent
排除标准
- •regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
- •medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)
结局指标
主要结局
Feasibility: Study completion rate
时间窗: 16 weeks
The proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Feasibility: Attendance rate
时间窗: 16 weeks
Participants' attendance to the supervised sessions will be recorded at each time point.
次要结局
- Change in frailty status(study entry, 8 weeks, 16 weeks)
- Change in Short Physical Performance Battery scores(study entry, 8 weeks, 16 weeks)
- Change in Short-Form Geriatric Depression Scale scores(study entry, 8 weeks, 16 weeks)
- Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores(study entry, 8 weeks, 16 weeks)
- Change in Modified Barthel Index scores(study entry, 8 weeks, 16 weeks)
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong