Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000383369
Ethics application status
Approved
Date submitted
10/07/2008
Date registered
1/08/2008
Date last updated
2/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Tai Chi for people with chronic obstructive pulmonary disease (COPD)
Scientific title
Does short-form Sun-style Tai Chi improve exercise capacity in people with chronic obstructive pulmonary disease (COPD)?: a single blind, randomised controlled trial
Secondary ID [1] 283400 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 3388 0
Condition category
Condition code
Respiratory 3534 3534 0 0
Chronic obstructive pulmonary disease
Alternative and Complementary Medicine 3535 3535 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sun-style Tai Chi exercise training
Short form Sun-style Tai Chi is a low-impact exercise which involves both upper and lower limb. This form consists of 21 moves in total and it was designed by Dr Lam, who is a general physician and Tai Chi master in Australia.
The duration of the course is 12 weeks (2 times per week for 12 weeks, about 1 hour each time)
Assessments, for exercise capacity, muscle strength, balance and health related quality of life, will be performed at baseline and also after 12 weeks Tai Chi training
Intervention code [1] 3112 0
Rehabilitation
Comparator / control treatment
The control group has no Tai Chi training. All participants will continue their standard medical care for the duration of the study - 12 weeks.
Pulmonary rehabilitation including exercise training and education will be offered after the study
Control group
Active

Outcomes
Primary outcome [1] 4439 0
exercise capacity - measured by the edurance shuttle walking test
Timepoint [1] 4439 0
at baseline (week 0) before randomisation and at the end of the study (at week 13)
Secondary outcome [1] 7494 0
health related quality of life - measured by chronic respiratory disease questionnaire
Timepoint [1] 7494 0
at baseline (week 0) before randomisation and at the end of the study (at week 13)
Secondary outcome [2] 7495 0
Lung function, lung volume and diffusion capacity - measured by full lung function test
Timepoint [2] 7495 0
at baseline (week 0) before randomisation
Secondary outcome [3] 7496 0
balance - measured by a series of balanace tests including semi-tandem and tandem standing, walking, sit to stand, single leg stance and functional reach test
Timepoint [3] 7496 0
at baseline (week 0) before randomisation and at the end of the study (at week 13)
Secondary outcome [4] 7497 0
subjective physical performance - measured by functional performance inventroy questionnaire
Timepoint [4] 7497 0
at baseline (week 0) before randomisation and at the end of the study (at week 13)
Secondary outcome [5] 7498 0
the acceptance of Tai Chi - measured by a subjective feedback questionnaire
Timepoint [5] 7498 0
at the end of the study (at week 13)

Eligibility
Key inclusion criteria
mild to severe COPD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological, acute cardiovascular diseases and other conditions that might limit the safe participation for exercise testing and training in this study

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)
participants will be randomised after initial baseline testing by a computer program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a computer-based program. The stratification is based on forced expiratory volume in the first second (FEV1) and gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
22/10/2008
Date of last participant enrolment
Anticipated
30/11/2011
Actual
22/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 996 0
2139

Funding & Sponsors
Funding source category [1] 3581 0
Self funded/Unfunded
Name [1] 3581 0
Country [1] 3581 0
Funding source category [2] 288119 0
Other
Name [2] 288119 0
Australia Physiotherapy Association, Physiotherapy research foundation seeding grant

Country [2] 288119 0
Australia
Funding source category [3] 288120 0
Other
Name [3] 288120 0
Ian Collier Memorial Scholarship - NSW Physiotherapist registration board
Country [3] 288120 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney Faculty of Health Sciences Cumberland Campus C42 75 East St Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 3217 0
Hospital
Name [1] 3217 0
Concord Repatriation General Hospital
Address [1] 3217 0
Hospital Road
Concord NSW 2139
Country [1] 3217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5623 0
Concord Hospital (Eastern Zone of Sydney South West Area Health Service Human Research Ethics Committee)
Ethics committee address [1] 5623 0
Concord Hosptial
Hospital Road
NSW 2139
Ethics committee country [1] 5623 0
Australia
Date submitted for ethics approval [1] 5623 0
Approval date [1] 5623 0
06/09/2008
Ethics approval number [1] 5623 0
08/CRGH/13

Summary
Brief summary
The aim of the project is to determine the effect on Tai Chi training on exercise capacity in people with COPD.

Hypothesis: On completion of an 12 week training program, subjects with COPD will demonstrate significant improvement in exercise capacity, compare with the control group with no Tai Chit raining.

Significance: If Tai Chi improves exercise capacity in people with COPD this would provide an alternate form of exercise training which does not require exercise equipment thus making effective exercise training more accessible for the large numbers of people with COPD.
Trial website
NA
Trial related presentations / publications
Related publication
Short-form Sun-style t’ai chi as an exercise training modality in people with COPD
Leung et al (2013) ERJ 41(5): 1051-1057

related presentation
1. Leung WMR, McKeough ZJ, Peters MJ and Alison JA, (2012) Tai Chi improves walking capacity, balance, quadriceps strength and quality of life in people with COPD. Respirology, 17 (suppl 1): p.32, TO-079
2. Leung WMR, McKeough ZJ, Peters MJ and Alison JA, (2012) The Tai Chi experience in people with COPD. Respirology, 17 (suppl 1): p. 59, TP-073
3. Leung WMR, Alison JA, McKeough ZJ and Peters MJ (2011) What is the exercise intensity of Sun-style Tai Chi in people with chronic obstructive pulmonary disease (COPD)?. Respirology, 16 (Suppl 2): p.106, TP-660
4. Leung WMR, Alison JA, McKeough ZJ and Peters MJ (2011) Sun-style Tai Chi achieves a moderate exercise training intensity in people with chronic obstructive pulmonary disease (COPD). Physiotherapy conference book, p. 42, 088
5. Leung WMR, Alison JA, McKeough ZJ and Peters MJ (2011) Exercise intensity of Sun-style Tai Chi in people with COPD. Respirology, 16 (suppl. 1): p.79, TP167
Public notes

Contacts
Principal investigator
Name 28736 0
Dr Wai Man Regina Leung
Address 28736 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country 28736 0
Australia
Phone 28736 0
+61297677602
Fax 28736 0
Email 28736 0
regina.leung@sswahs.nsw.gov.au
Contact person for public queries
Name 11893 0
Dr Wai Man Regina Leung
Address 11893 0
Institute of sports Medicine
Hospital Road
Concord NSW 2139
Country 11893 0
Australia
Phone 11893 0
(02) 97677602
Fax 11893 0
Email 11893 0
regina.leung@sswahs.nsw.gov.au
Contact person for scientific queries
Name 2821 0
Prof Associate Professor Jenny Alison
Address 2821 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
Cumberland Campus C42
75 East St
Lidcombe NSW 2141
Country 2821 0
Australia
Phone 2821 0
(02) 93519371
Fax 2821 0
Email 2821 0
jennifer.alison@sydney.edu.au

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

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