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Completed

NCT Number: NCT02054377

Cystic Fibrosis- Children and Adults Tai Chi Study

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

Other

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.

Primary outcomes

  1. Cystic Fibrosis Questionnaire (CFQ-R )

    Time frame: Change from baseline at 3 months

    • 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)

  2. Cystic Fibrosis Questionnaire (CFQ-R )

    Time frame: Change from baseline at 6 months

    • 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)

  3. Cystic Fibrosis Questionnaire (CFQ-R )

    Time frame: Change from baseline at 9 months

    • 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)

Secondary outcomes

  1. Five facets mindfulness scale

    Time frame: Change from baseline at 3 months

    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management

  2. Five facets mindfulness scale

    Time frame: Change from baseline at 6 months

    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management

  3. Five facets mindfulness scale

    Time frame: Change from baseline at 9 months

    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management

Other outcomes

  1. Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: Change from baseline at 3 months

    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline at 3 months

    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.

  3. Routine clinical data from hospital records

    Time frame: Change from baseline at 3 months

    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)

  4. Modified Borg dyspnoea scale

    Time frame: Before and after each tai chi session

    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)

  5. Changes that week

    Time frame: Before and after each tai chi session

    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

  6. Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: Change from baseline at 6 months

    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  7. Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: Change from baseline at 9 months

    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline at 6 months

    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.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline at 9 months

    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.

  10. Routine clinical data from hospital records

    Time frame: Change from baseline at 6 months

    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)

  11. Routine clinical data from hospital records

    Time frame: Change from baseline at 9 months

    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)

  12. Modified Borg dyspnoea scale

    Time frame: Change from baseline to 4 months

    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)

  13. Modified Borg dyspnoea scale

    Time frame: Change from baseline to 5 months

    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)

  14. Modified Borg dyspnoea scale

    Time frame: Change from baseline to 7 months

    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)

  15. Modified Borg dyspnoea scale

    Time frame: Change from baseline to 9 months

    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)

  16. Changes that week

    Time frame: Changes from baseline to 4 months

    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

  17. Changes that week

    Time frame: Changes from baseline to 5 months

    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

  18. Changes that week

    Time frame: Changes from baseline to 7 months

    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

  19. Changes that week

    Time frame: Changes from baseline to 9 months

    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

Sponsors and collaborators

Lead sponsor

London South Bank University

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study 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

Acronym: CFCATS2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2014
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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