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

March 12, 2018 updated by: London South Bank University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline at 3 months
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)
Change from baseline at 6 months
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)
Change from baseline at 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at 3 months
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
Change from baseline at 6 months
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
Change from baseline at 9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 3 months
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.
Change from baseline at 3 months
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)
Change from baseline at 3 months
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)
Before and after each tai chi session
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
Before and after each tai chi session
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.
Change from baseline at 6 months
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.
Change from baseline at 9 months
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.
Change from baseline at 6 months
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.
Change from baseline at 9 months
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)
Change from baseline at 6 months
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)
Change from baseline at 9 months
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)
Change from baseline to 4 months
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)
Change from baseline to 5 months
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)
Change from baseline to 7 months
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)
Change from baseline to 9 months
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
Changes from baseline to 4 months
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
Changes from baseline to 5 months
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
Changes from baseline to 7 months
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
Changes from baseline to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicola Robinson, PhD, LSBU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2014

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (ESTIMATE)

February 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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