Ignite Creation Date:
2024-05-06 @ 2:30 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054377
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2014-01-30
Brief Title:
Cystic Fibrosis- Children and Adults Tai Chi Study
Sponsor:
London South Bank University
Organization:
London South Bank University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CFCATS2
Brief 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 schoolwork
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 etcwill 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
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 etcwill 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None