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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by London South Bank University
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
London South Bank University
ClinicalTrials.gov Identifier:
NCT02054377
First received: January 30, 2014
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Other: Tai chi

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by London South Bank University:

Primary Outcome Measures:
  • Cystic Fibrosis Questionnaire (CFQ-R ) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    • 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)

  • Cystic Fibrosis Questionnaire (CFQ-R ) [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    • 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)

  • Cystic Fibrosis Questionnaire (CFQ-R ) [ Time Frame: Change from baseline at 9 months ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • Five facets mindfulness scale [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management

  • Five facets mindfulness scale [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management

  • Five facets mindfulness scale [ Time Frame: Change from baseline at 9 months ] [ Designated as safety issue: No ]
    The five facets scale is a 39 item questionnaire about awareness of thoughts, anxieties, self-management


Other Outcome Measures:
  • Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    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.

  • Routine clinical data from hospital records [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    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)

  • Modified Borg dyspnoea scale [ Time Frame: Before and after each tai chi session ] [ Designated as safety issue: No ]
    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)

  • Changes that week [ Time Frame: Before and after each tai chi session ] [ Designated as safety issue: No ]
    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor

  • Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  • Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: Change from baseline at 9 months ] [ Designated as safety issue: No ]
    CAMM is a 10 item questionnaire about awareness of thoughts, anxieties, self-management.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    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.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline at 9 months ] [ Designated as safety issue: No ]
    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.

  • Routine clinical data from hospital records [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    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)

  • Routine clinical data from hospital records [ Time Frame: Change from baseline at 9 months ] [ Designated as safety issue: No ]
    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)

  • Modified Borg dyspnoea scale [ Time Frame: Change from baseline to 4 months ] [ Designated as safety issue: No ]
    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)

  • Modified Borg dyspnoea scale [ Time Frame: Change from baseline to 5 months ] [ Designated as safety issue: No ]
    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)

  • Modified Borg dyspnoea scale [ Time Frame: Change from baseline to 7 months ] [ Designated as safety issue: No ]
    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)

  • Modified Borg dyspnoea scale [ Time Frame: Change from baseline to 9 months ] [ Designated as safety issue: No ]
    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)

  • Changes that week [ Time Frame: Changes from baseline to 4 months ] [ Designated as safety issue: No ]
    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 that week [ Time Frame: Changes from baseline to 5 months ] [ Designated as safety issue: No ]
    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 that week [ Time Frame: Changes from baseline to 7 months ] [ Designated as safety issue: No ]
    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 that week [ Time Frame: Changes from baseline to 9 months ] [ Designated as safety issue: No ]
    Details of any changes in medication, exacerbations, antibiotic use, clinical trial participation, or care provision (start of session only), asked verbally by the instructor


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (face to face tai chi)
  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.
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.

Active Comparator: Group 2 (online tai chi)
  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.
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.


  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054377

Contacts
Contact: Ava Lorenc, PhD 00442078158475 lorenca@lsbu.ac.uk
Contact: Nicola Robinson, PhD 00442078157940 nicky.robinson@lsbu.ac.uk

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Susan Madge       S.Madge@rbht.nhs.uk   
Sub-Investigator: Susan Madge         
Sponsors and Collaborators
London South Bank University
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Nicola Robinson, PhD LSBU
  More Information

Additional Information:
No publications provided

Responsible Party: London South Bank University
ClinicalTrials.gov Identifier: NCT02054377     History of Changes
Other Study ID Numbers: 6463
Study First Received: January 30, 2014
Last Updated: July 14, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by London South Bank University:
cystic fibrosis
tai chi

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014