Clinical trial NCT02054377: Cystic Fibrosis- Children and Adults Tai Chi Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
tai chi
Lead sponsor: London South Bank University
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2014-02-04
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cystic Fibrosis Questionnaire (CFQ-R )
timeFrame: Change from baseline at 3 months
measure: Cystic Fibrosis Questionnaire (CFQ-R )
timeFrame: Change from baseline at 6 months
measure: Cystic Fibrosis Questionnaire (CFQ-R )
timeFrame: Change from baseline at 9 months
Secondary outcomes:
measure: Five facets mindfulness scale
timeFrame: Change from baseline at 3 months
measure: Five facets mindfulness scale
timeFrame: Change from baseline at 6 months
measure: Five facets mindfulness scale
timeFrame: Change from baseline at 9 months
Other outcomes:
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Change from baseline at 3 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline at 3 months
measure: Routine clinical data from hospital records
timeFrame: Change from baseline at 3 months
measure: Modified Borg dyspnoea scale
timeFrame: Before and after each tai chi session
measure: Changes that week
timeFrame: Before and after each tai chi session
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Change from baseline at 6 months
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Change from baseline at 9 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline at 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline at 9 months
measure: Routine clinical data from hospital records
timeFrame: Change from baseline at 6 months
measure: Routine clinical data from hospital records
timeFrame: Change from baseline at 9 months
measure: Modified Borg dyspnoea scale
timeFrame: Change from baseline to 4 months
measure: Modified Borg dyspnoea scale
timeFrame: Change from baseline to 5 months
measure: Modified Borg dyspnoea scale
timeFrame: Change from baseline to 7 months
measure: Modified Borg dyspnoea scale
timeFrame: Change from baseline to 9 months
measure: Changes that week
timeFrame: Changes from baseline to 4 months
measure: Changes that week
timeFrame: Changes from baseline to 5 months
measure: Changes that week
timeFrame: Changes from baseline to 7 months
measure: Changes that week
timeFrame: Changes from baseline to 9 months
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: LSBU
name: Nicola Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ronan P, Mian A, Carr SB, Madge SL, Lorenc A, Robinson N. Learning to breathe with Tai Chi online - qualitative data from a randomized controlled feasibility study of patients with cystic fibrosis. Eur J Integr Med. 2020 Dec;40:101229. doi: 10.1016/j.eujim.2020.101229. Epub 2020 Oct 22.
citation: Lorenc AB, Wang Y, Madge SL, Hu X, Mian AM, Robinson N. Meditative movement for respiratory function: a systematic review. Respir Care. 2014 Mar;59(3):427-40. doi: 10.4187/respcare.02570. Epub 2013 Jul 23.
citation: Lorenc A, Ronan P, Mian A, Madge S, Carr SB, Agent P, Robinson N. 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. Chin J Integr Med. 2015 May 26. doi: 10.1007/s11655-015-2150-1. Online ahead of print.
citation: RONAN, P., MIAN, A., LORENC, A., CARR, S., MADGE, S. & ROBINSON, N. 2015b. CF-CATS2: Using technology to integrate Tai Chi into medical treatments for people with cystic fibrosis - An RCT. European Journal of Integrative Medicine, 7, Supplement 1, 47.
citation: RONAN, P., MIAN, A., LORENC, A., CARR, S., MADGE, S. & ROBINSON, N. 2015a. CF-CATS2: Is it feasible to use web-based technology to teach Tai Chi in order to integrate it into routine medical treatment for people with cystic fibrosis? European Journal of Integrative Medicine, 7, 693-694.