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Trial registered on ANZCTR


Registration number
ACTRN12613000029796
Ethics application status
Approved
Date submitted
9/01/2013
Date registered
10/01/2013
Date last updated
10/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Tai Chi on quality of life of older people living in long-term care and using wheelchairs for mobility.
Scientific title
The effect of Tai Chi on quality of life of older people living in long-term care and using wheelchairs for mobility: A randomized controlled clinical trial.
Secondary ID [1] 281697 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability 287985 0
Old age 287986 0
Condition category
Condition code
Alternative and Complementary Medicine 288368 288368 0 0
Other alternative and complementary medicine
Other 288369 288369 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seated in wheelchair, an intervention group undertook three 40-minute sessions each week of Simplified Tai Chi Exercise Program (STEP) for a period of 26 weeks. The Tai Chi exercise program was conducted by a qualified instructor from Taiwan's Tai Chi Chuan Association. The group of 30 participants randomized into the intervention group was further split into two smaller group of 15 participants due to space constraints and to ensure a quality learning experience.
Intervention code [1] 286234 0
Treatment: Other
Comparator / control treatment
Control group received usual standard care with no seated Tai Chi exercise during the period of 26 weeks.
Control group
Active

Outcomes
Primary outcome [1] 288540 0
Quality of Life (QoL) using the World Health Organization Quality of Life BREF
Timepoint [1] 288540 0
1) Week 1 (Baseline)
2) Week 13 follow-up
3) Week 26 follow-up
Secondary outcome [1] 300424 0
Depression state using Geriatric Depression Scale - Short Form (GDS-SF)
Timepoint [1] 300424 0
1) Week 1 (Baseline)
2) Week 13 follow-up
3) Week 26 follow-up
Secondary outcome [2] 300425 0
Mood States using Profile of Mood States Short Form (POMS-SF)
Timepoint [2] 300425 0
1) Week 1 (Baseline)
2) Week 13 follow-up
3) Week 26 follow-up
Secondary outcome [3] 300426 0
Participants' perception of their confidence using Self-Efficacy for Exercise (SEE) Scale
Timepoint [3] 300426 0
1) Week 1 (Baseline)
2) Week 13 follow-up
3) Week 26 follow-up

Eligibility
Key inclusion criteria
1) people in wheelchairs
2) willingness to participate in the study
3) able to speak and understand Chinese or Taiwanese and with no severe hearing impairment
4) able to use and raise both arms while sitting in a wheelchair
5) able to provide informed consent
6) cognitive function established through Mini Mental State Examination >24/30
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) symptoms of acute pain or infection
2) any lower extremity infection
3) older people in palliative care
4) older people who were blind
5) documented or observable psychiatric or neurological disorders that might interfere with participation (for example dementia, or psychosis).

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)
Group allocation list was concealed from those involved in the research and placed in an opaque and sealed envelope until the allocation of participants to their groups was fully completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly assigned into one of two parallel groups in a 1:1 ratio. A consultant statistician provided a computer-generated randomization list using the Excel Randomization Function, using a 1:1 allocation ratio. The list generated consisted of the participant numbers (1–60) and a number indicating which group that participant had been randomly allocated to: “0” indicated the control group; “1” indicated the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4762 0
Taiwan, Province Of China
State/province [1] 4762 0
Changhua region

Funding & Sponsors
Funding source category [1] 286486 0
Self funded/Unfunded
Name [1] 286486 0
Unfunded - None
Address [1] 286486 0
Unfunded - None
Country [1] 286486 0
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road,
Nathan, Brisbane,
QLD 4111
Country
Australia
Secondary sponsor category [1] 285277 0
None
Name [1] 285277 0
Address [1] 285277 0
Country [1] 285277 0
Other collaborator category [1] 277242 0
Other Collaborative groups
Name [1] 277242 0
Jen-Tao LTC Facility
Address [1] 277242 0
No, 29, Shanjiao Rd 15 Iane,
Shetou Township,
Changhua County 51143.
Country [1] 277242 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288563 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288563 0
170 Kessels Road
Nathan, Brisbane
QLD 4111
Ethics committee country [1] 288563 0
Australia
Date submitted for ethics approval [1] 288563 0
Approval date [1] 288563 0
21/07/2010
Ethics approval number [1] 288563 0
NRS/17/10/HREC

Summary
Brief summary
This study aims to determine the effect of a 26-week seated Simplified Tai Chi Exercise Program (STEP) on the quality of life of older Taiwanese people in wheelchairs living in long term care, and on their depression, mood states, and self-efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36694 0
Prof Wendy Moyle
Address 36694 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 36694 0
Australia
Phone 36694 0
+61 (0) 7 3735 5526
Fax 36694 0
Email 36694 0
w.moyle@griffith.edu.au
Contact person for public queries
Name 36695 0
Prof Wendy Moyle
Address 36695 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 36695 0
Australia
Phone 36695 0
+61 (0) 7 3735 5526
Fax 36695 0
Email 36695 0
w.moyle@griffith.edu.au
Contact person for scientific queries
Name 36696 0
Prof Marie Cooke
Address 36696 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 36696 0
Australia
Phone 36696 0
+61 7 3735 5253
Fax 36696 0
Email 36696 0
m.cooke@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary