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Trial registered on ANZCTR


Registration number
ACTRN12617000242325
Ethics application status
Approved
Date submitted
22/01/2017
Date registered
16/02/2017
Date last updated
16/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Tai Chi for people with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Does Tai Chi increase cerebral and peripheral oxygenation and do these changes relate to improved cognitive and physical performance in people with Chronic Obstructive Pulmonary Disease (COPD)? A randomised controlled trial
Secondary ID [1] 290985 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 301739 0
Condition category
Condition code
Respiratory 301436 301436 0 0
Chronic obstructive pulmonary disease
Alternative and Complementary Medicine 301437 301437 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tai Chi Group:
Participants, in a group of 4-6, will join 2 supervised sessions of Tai Chi (Sun-Style Tai Chi) per week supervised by a research personnel with experience of practicing Sun-Style Tai Chi in an outpatient setting. Each session will last for 60 minutes including warm up, Tai chi and cool down.
All participants are advised to practice daily at home following what they have practiced in the supervised session with practice duration similar to supervised session. All participants will have an accelerometer (to be worn at wrist) to record their level of physical activities and an exercise logbook for recording.The whole program will last for 12 weeks.
Intervention code [1] 296939 0
Treatment: Other
Intervention code [2] 297026 0
Lifestyle
Comparator / control treatment
1) Exercise group
Participants, in a group of 4-6, will join 2 supervised exercise sessions per week supervised by a research personnel in an outpatient setting. Each session will last for 60 minutes including warm up, exercise (ergometer at the moderate intensity of exercise, i.e. about 3-4 out of 10 of modified Borg Scale), and cool down

All participants will have an accelerometer (to be worn at wrist) to record their level of physical activities and an exercise logbook for recording. The whole program will last for 12 weeks.

2) Routine care group - participants are advised to continue their usual activities
All participants will have an accelerometer (to be worn at wrist) to record their level of physical activities and an exercise logbook for recording. The whole program will last for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300828 0
Cognitive performance will be assessed by trail making test, digit span test and calculation.
Timepoint [1] 300828 0
End of 12-week program
Primary outcome [2] 300829 0
Physical performance will be assessed by symptom limited ergometry test.
Timepoint [2] 300829 0
End of 12-week program
Primary outcome [3] 301039 0
Cerebral oxygenation will be measured during cognitive tests while tissue oxygenation of respiratory muscle and quadriceps will be measured during ergometry by Near Infrared Spectroscopy.
Timepoint [3] 301039 0
End of 12-week program
Secondary outcome [1] 330973 0
6-minute walk distance will be assessed by 6-minute walk test
Timepoint [1] 330973 0
End of 12-week program
Secondary outcome [2] 330977 0
Strength of quadriceps will be assessed by isokinetic dynamometer.
Timepoint [2] 330977 0
End of 12-week program
Secondary outcome [3] 330978 0
Level of physical activities (by accelerometer)
Timepoint [3] 330978 0
End of 12-week program
Secondary outcome [4] 331195 0
Quality of life will be assessed by St. George's Respiratory Questionnaire (SGRQ)
Timepoint [4] 331195 0
End of 12-week program

Eligibility
Key inclusion criteria
Participants aged more than or equal to 55; with medical diagnosis of COPD, following the guidelines of Global Initiative for Chronic Obstructive Lung Disease (GOLD), with a ratio of post-bronchodilator forced expiratory flow volume in one second (FEV1)/ Forced Vital Capacity (FVC) of <70%; and GOLD stage II or above (i.e. FEV1<80% predicted)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with confirmed diagnosis of cognitive impairment such as Alzheimer’s disease; or neurological disorders such as stroke; or Diabetes mellitus that may influence blood flow at cerebral and tissue (i.e. muscle) level; or Unstable cardiovascular disease or recent musculoskeletal disorders that may affect their exercise performance

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way mixed-model ANOVA will be used to evaluate the change of outcome measures with between-subject factor (groups) and within-subject factor (time).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 8600 0
China
State/province [1] 8600 0
Hong Kong

Funding & Sponsors
Funding source category [1] 295401 0
Government body
Name [1] 295401 0
Research Grants Council
Country [1] 295401 0
China
Primary sponsor type
University
Name
Dr. Shirley Ngai
Address
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China
Country
China
Secondary sponsor category [1] 294224 0
None
Name [1] 294224 0
Address [1] 294224 0
Country [1] 294224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296734 0
Departmental Research Committee, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Ethics committee address [1] 296734 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China
Ethics committee country [1] 296734 0
China
Date submitted for ethics approval [1] 296734 0
26/01/2015
Approval date [1] 296734 0
06/02/2015
Ethics approval number [1] 296734 0
HSEARS20150126002

Summary
Brief summary
This study aims to evaluate the effect of a 12-week Tai Chi programme on people with COPD. We hypothesize that after 12-week programme, participants receiving Tai Chi training will have better cognitive and physical performance when compared with control groups.
Trial website
Not applicable
Trial related presentations / publications
No
Public notes

Contacts
Principal investigator
Name 71922 0
Dr Shirley Ngai
Address 71922 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China
Country 71922 0
China
Phone 71922 0
+852 27664801
Fax 71922 0
Email 71922 0
shirley.ngai@polyu.edu.hk
Contact person for public queries
Name 71923 0
Shirley Ngai
Address 71923 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China
Country 71923 0
China
Phone 71923 0
+852 27664801
Fax 71923 0
Email 71923 0
shirley.ngai@polyu.edu.hk
Contact person for scientific queries
Name 71924 0
Shirley Ngai
Address 71924 0
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China
Country 71924 0
China
Phone 71924 0
+852 27664801
Fax 71924 0
Email 71924 0
shirley.ngai@polyu.edu.hk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.