Cystic Fibrosis- Children and Adults Tai Chi Study (CFCATS2)

London South Bank University

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Tai chi

Study type: Interventional

Funder types: Other

Identifiers

NCT02054377

6463

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 6 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Group A (face to face tai chi)

Experimental group

Description:

1. 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. 2. Daily home Tai Chi practise for 6 months (home practice encouraged for 5 to 10mins 5 times a week). 3. At the end of the 9 months, local Tai Chi classes can be recommended if requested.

Treatment:

Other: Tai chi

Group 2 (online tai chi)

Active Comparator group

Description:

1. 3 months usual routine care. 2. 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. 3. Daily Tai Chi home practise for 6 months (home practice encouraged for 5 to 10mins 5 times a week). 4. At the end of the 9 months, local Tai Chi classes can be recommended if requested.

Treatment:

Other: Tai chi