title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: London South Bank University, London, SE1 OAA, UK.
authors.forename: Ava
authors.initials: A
authors.lastname: Lorenc
authors.forename: Patricia
authors.initials: P
authors.lastname: Ronan
authors.forename: Awais
authors.initials: A
authors.lastname: Mian
authors.forename: Susan
authors.initials: S
authors.lastname: Madge
authors.forename: Siobhan B
authors.initials: SB
authors.lastname: Carr
authors.forename: Penny
authors.initials: P
authors.lastname: Agent
authors.forename: Nicola
authors.initials: N
authors.lastname: Robinson