Cystic Fibrosis- Children and Adults Tai Chi Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Tai chi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: participant in the feasibility phase currently taking part in another interventional research study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (face to face tai chi)<br>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. | Other: Tai chi<br>* Tai Chi, a Chinese form of mindful exercise, may help alleviate CF symptoms, encourage active self-management and provide a practical way to relieve and manage stress for patients and carers. It involves gentle physical exercises, combined with breathing techniques and mindful awareness. It will be taught by qualified instructors either face to face in the participant's home or over videoconferencing technology e.g. Skype. A DVD of the Tai Chi was developed in Phase 1 which was successful for teaching adults, and will be used here, along with a child-friendly DVD. This will be filmed with and aimed at children aged 6-18. Teaching support materials, incorporating child-specific guidance such as animal-based Tai Chi movements, will be prepared for use in conjunction with the DVD.<br>|
| Active Comparator: Group 2 (online tai chi)<br>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. | Other: Tai chi<br>* Tai Chi, a Chinese form of mindful exercise, may help alleviate CF symptoms, encourage active self-management and provide a practical way to relieve and manage stress for patients and carers. It involves gentle physical exercises, combined with breathing techniques and mindful awareness. It will be taught by qualified instructors either face to face in the participant's home or over videoconferencing technology e.g. Skype. A DVD of the Tai Chi was developed in Phase 1 which was successful for teaching adults, and will be used here, along with a child-friendly DVD. This will be filmed with and aimed at children aged 6-18. Teaching support materials, incorporating child-specific guidance such as animal-based Tai Chi movements, will be prepared for use in conjunction with the DVD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystic Fibrosis Questionnaire (CFQ-R ) | • 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) | Change from baseline at 3 months | 
| Cystic Fibrosis Questionnaire (CFQ-R ) | • 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) | Change from baseline at 6 months | 
| Cystic Fibrosis Questionnaire (CFQ-R ) | • 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) | Change from baseline at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five facets mindfulness scale | The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management | Change from baseline at 3 months | 
| Five facets mindfulness scale | The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management | Change from baseline at 6 months | 
| Five facets mindfulness scale | The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management | Change from baseline at 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, tai chi