Cystic Fibrosis- Children and Adults Tai Chi Study: Can Tai Chi Improve Quality of Life for People With Cystic Fibrosis and Their Carers? Second Phase Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Cystic Fibrosis Questionnaire (CFQ-R )
研究概览
简要总结
Cystic fibrosis (CF) is a progressive disease. Symptoms include coughing, poor lung ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress, frustration, depression, irritability, worry, insomnia, behavioural issues and missed school/work.
Tai chi, a Chinese form of exercise, uses slow choreographed movements, breathing exercises and mindfulness. Research suggests tai chi can improve physical and emotional wellbeing for various chronic conditions.
This study compares methods of teaching tai chi to 70 people with CF, and evaluates the effect on symptoms and quality of life. Adults and children with CF will be recruited and randomly allocated to an intervention group or a control group. The former will receive 8 individual face to face sessions of tai chi over a 3 month period and a video and handouts to aid home practice. The latter will have routine care for the first 12 weeks, followed by 8 individual online sessions of tai chi over a 3 month period, and a video and handouts for home practice.
Both groups will be encouraged to practice tai chi at home in the months following the taught sessions.
Questionnaire data on how participants and their carers are coping with CF, any general improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will be collected. Data will be collected at the beginning and end of the intervention, and at 6 and 9 months post intervention and differences between the 2 groups compared over time.
Feedback from on line focus groups will ask about their experiences, feasibility of learning and practicing of tai chi, engagement with the process, perceived health impact, and experiences of participation.
It is hoped that the study may show how Tai Chi can help people with CF to maintain their health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.
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
- None
入排标准
- 年龄范围
- 6 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CF
- •no previous experience in Tai Chi, but ability/potential to undertake these movements
- •able to commit to a 9 month study
- •living in or near London or Brighton (depending on teacher locations)
- •able to understand, read and write English
- •6 years old and above
- •to have internet access for web based learning
排除标准
- •participant in the feasibility phase
- •currently taking part in another interventional research study
研究组 & 干预措施
Group A (face to face tai chi)
- 8 x 1 hour taught individual classes of Tai Chi over 3 months provided by a Tai Chi instructor at the participant's home/convenient location. These focus on 8 core postures. This is in addition to participant's usual routine care. A DVD and booklet to aid home practise will be provided.
- Daily home Tai Chi practise for 6 months (home practice encouraged for 5 to 10mins 5 times a week).
- At the end of the 9 months, local Tai Chi classes can be recommended if requested.
干预措施: Tai chi (Other)
Group 2 (online tai chi)
- 3 months usual routine care.
- 8 x 1 hour taught individual classes of Tai Chi over 3 months provided over the internet by a Tai Chi instructor. A DVD and booklet to aid home practise will be provided.
- Daily Tai Chi home practise for 6 months (home practice encouraged for 5 to 10mins 5 times a week).
- At the end of the 9 months, local Tai Chi classes can be recommended if requested.
干预措施: Tai chi (Other)
结局指标
主要结局
Cystic Fibrosis Questionnaire (CFQ-R )
时间窗: Change from baseline at 9 months
• Cystic Fibrosis Questionnaire-Revised (CFQ-R), a disease-specific instrument (Quittner et al 2005; Modi \& Quittner 2003). The CFQ uses 5 point Likert scales in 9 quality of life domains (physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions), 3 symptoms (weight, respiratory, and digestion) and health perception. CFQ-R was seen as acceptable, appropriate and easily completed in the feasibility study. There are four different versions of the CFQ-R which will be used as appropriate: Adult/adolescent version completed by the patient for those 14 and over; 12-13 year old version completed by the patient; parent CFQ for children aged 6 to 13; for children 6 to 11 child CFQ in interviewer format (parent/carer)
次要结局
- Five facets mindfulness scale(Change from baseline at 9 months)