Cystic Fibrosis- Children and Adults Tai Chi Study

Cystic Fibrosis Clinical Trial

— CFCATS2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054377
• Other study ID #: 6463
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: March 12, 2018
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2018
• Source: London South Bank University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Tai chi
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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
London South Bank University	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Lorenc A, Mian A, Madge S, Carr S, Robinson N (2013) CF-CATS: An uncontrolled feasibility study of using tai chi for adults with cystic fibrosis. European Journal of Integrative Medicine. 5: 476-486

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. [Epub ahead of print] — View Citation

Lorenc A, Wang Y, Madge SL, Hu X, Mian AM, Robinson N. (2013) Meditative movement for cystic fibrosis/respiratory function: a systematic review. Journal of Respiratory Care. doi: 10.4187/respcare.02570

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child and Adolescent Mindfulness Measure (CAMM)	CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.	Change from baseline at 3 months
Other	Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989), a 10 item questionnaire about sleep quality and duration. This will be completed by the parent/carer for children under 12.	Change from baseline at 3 months
Other	Routine clinical data from hospital records	Changes in general health and respiratory function will be measured using routine clinical data from hospital records, to include: Body Mass Index (BMI), medications, antibiotic use, Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), and oxygen saturation (amount of oxygen in red blood cells)	Change from baseline at 3 months
Other	Modified Borg dyspnoea scale	Modified Borg dyspnoea scale is a one item, 10 point scale that rates comfort of breathing (American Thoracic Society, 2002, Borg and Borg, 2002, Borg, 1970)	Before and after each tai chi session
Other	Changes that week	Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor	Before and after each tai chi session
Other	Child and Adolescent Mindfulness Measure (CAMM)	CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.	Change from baseline at 6 months
Other	Child and Adolescent Mindfulness Measure (CAMM)	CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.	Change from baseline at 9 months
Other	Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989), a 10 item questionnaire about sleep quality and duration. This will be completed by the parent/carer for children under 12.	Change from baseline at 6 months
Other	Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989), a 10 item questionnaire about sleep quality and duration. This will be completed by the parent/carer for children under 12.	Change from baseline at 9 months
Other	Routine clinical data from hospital records	Changes in general health and respiratory function will be measured using routine clinical data from hospital records, to include: Body Mass Index (BMI), medications, antibiotic use, Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), and oxygen saturation (amount of oxygen in red blood cells)	Change from baseline at 6 months
Other	Routine clinical data from hospital records	Changes in general health and respiratory function will be measured using routine clinical data from hospital records, to include: Body Mass Index (BMI), medications, antibiotic use, Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), and oxygen saturation (amount of oxygen in red blood cells)	Change from baseline at 9 months
Other	Modified Borg dyspnoea scale	Modified Borg dyspnoea scale is a one item, 10 point scale that rates comfort of breathing (American Thoracic Society, 2002, Borg and Borg, 2002, Borg, 1970)	Change from baseline to 4 months
Other	Modified Borg dyspnoea scale	Modified Borg dyspnoea scale is a one item, 10 point scale that rates comfort of breathing (American Thoracic Society, 2002, Borg and Borg, 2002, Borg, 1970)	Change from baseline to 5 months
Other	Modified Borg dyspnoea scale	Modified Borg dyspnoea scale is a one item, 10 point scale that rates comfort of breathing (American Thoracic Society, 2002, Borg and Borg, 2002, Borg, 1970)	Change from baseline to 7 months
Other	Modified Borg dyspnoea scale	Modified Borg dyspnoea scale is a one item, 10 point scale that rates comfort of breathing (American Thoracic Society, 2002, Borg and Borg, 2002, Borg, 1970)	Change from baseline to 9 months
Other	Changes that week	Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor	Changes from baseline to 4 months
Other	Changes that week	Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor	Changes from baseline to 5 months
Other	Changes that week	Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor	Changes from baseline to 7 months
Other	Changes that week	Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor	Changes from baseline to 9 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Information about the funder
•   Information about the funder
•   Trailer for the study on you tube