Cystic fibrosis-Children and adults Tai Chi study (CF CATS2): Can Tai Chi improve symptoms and quality of life for people with cystic fibrosis? Second phase study protocol.

BACKGROUND: Cystic fibrosis (CF) is a genetic disorder affecting respiratory and digestive systems. People with CF experience physical symptoms; cough, poor lung ventilation, recurrent infections, poor weight gain, diarrhoea, and malnutrition, as well as lower quality of life. Tai Chi, a Chinese form of meditative movement, may help with the symptoms of CF and help people with CF to exercise. However, there is very little research in this area.

OBJECTIVE: To evaluate the feasibility of studying Tai Chi for CF and to compare the effectiveness of Tai Chi to standard care and face-to-face Tai Chi with online Tai Chi for people with CF.

METHODS: This is a comparative effectiveness trial with 72 people with CF over 6 years old and a patient at the Royal Brompton Hospital, London, UK. Participants receive 8 Tai Chi sessions, then home practice with a DVD. Sessions are one-on-one for group A, online for group B. Group B is a no treatment standard care control (first 3 months). At baseline, 3, 6 and 9 months, questionnaires will be used to measure quality of life, mindfulness and sleep, and medical data health and respiratory function. At Tai Chi sessions and at 4 follow-up points, the Borg Scale and healthcare use data will be collected. At 9 months online focus groups will assess participants' experience, Tai Chi feasibility, perceived health impact, and study participation. Recruitment will use adverts in hospital clinics and website, and letter/phone for non-regularly attending patients. Block randomisation will use random number tables. The two groups will be compared for: weeks 1 to 12 (Tai Chi vs. standard care); before and after intervention (differences in delivery method); week 1 (of intervention) to month 9 (long-term impact). Qualitative data will use Framework analysis.

DISCUSSION: We believe this is the first trial of Tai Chi for CF. Tai Chi may help with the physiological symptoms of CF and increase levels of exercise by providing a self-management technique and low stress activity. This study will provide data on the feasibility of a randomized controlled trial of Tai Chi for CF, including data for a sample size calculation and will inform future study design.