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Trial registered on ANZCTR


Registration number
ACTRN12617001628336
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
13/12/2017
Date last updated
13/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a combination of Tai Chi plus Thera-bands on stress, depression, anxiety, pain, ans well-being in older sedentary office workers: a pilot randomized controlled trial
Scientific title
Effectiveness of a combination of Tai Chi plus Thera-bands on stress, depression, anxiety, pain, ans well-being in older sedentary office workers: a pilot randomized controlled trial
Secondary ID [1] 293460 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 305641 0
depression 305643 0
anxiety 305644 0
pain 305645 0
Falls 305769 0
Condition category
Condition code
Public Health 304869 304869 0 0
Health promotion/education
Mental Health 304992 304992 0 0
Anxiety
Mental Health 304993 304993 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group used Tai Chi combined with resistance training (i.e. Thera-band resistance training). The first 10 forms of the Yang style Tai Chi was used. Participants practiced Tai Chi while holding a Thera-band by both hands three time per week for 12 weeks plus a 2-week learning stage. Each session lasted for 45 minutes, including 10-minute warm up, 30-minute Tai Chi plus Thera-band exercise, and 5-minutes cool down. The resistance training was performed using Thera-Band®, The Hygenic Corporation, Akron, OH, USA.

One professional Tai Chi teacher conducted the sessions, each session had a minimum 1 person, and maximum 5 person. The intervention was undertaken in Griffith University, QLD, Australia (Nathan campus, Mount Gravatt campus, and Gold Coast campus). Sessions were conducted in the seminar rooms in these three campuses of Griffith University. Tai Chi and resistance training were administered during the same sessions. Attendance rate was recorded by signing participants' names on the attendance table of each session. Class capacity was also recorded.

Resistance training was used in conformed to the guideline of physical activity recommended for the elderly. Participants used the low resistance intensity at learning stage, and then adjusted to the higher intensity every fortnight if participants reported their rating of perceived exertion (RPE) at a level below five on the RPE scale during the intervention. Exercise intensity was progressively increased by adjusting the width of grip (based on the Thera-Band® force-elongation table) or adapting the resistance of the Thera-bands from tan to yellow and further to black.
Intervention code [1] 299702 0
Treatment: Other
Comparator / control treatment
Control group used Tai Chi exercise (i.e. the first 10 forms of Yang style Tai Chi)

The first 10 forms of the Yang style Tai Chi was used. Participants practiced Tai Chi three time per week for 12 week splus a 2-week learning stage. Each session lasted for 45 minutes, including 10-minute warm up, 30-minute Tai Chi exercise, and 5-minutes cool down.

One professional Tai Chi teacher conducted the sessions, each session had a minimum 1 person, and maximum 5 person. The intervention was undertaken in Griffith University, QLD, Australia (Nathan campus, Mount Gravatt campus, and Gold Coast campus). Sessions were conducted in the seminar rooms in these three campuses of Griffith University. Attendance rate was recorded by signing participants' names on the attendance table of each session. Class capacity was also recorded each session.
Control group
Active

Outcomes
Primary outcome [1] 304062 0
Stress (Perceived Stress Scale)
Timepoint [1] 304062 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Primary outcome [2] 304063 0
Depression (Centre for Epidemiological Studies Depression Scale version 10)
Timepoint [2] 304063 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Primary outcome [3] 304159 0
Anxiety (Geriatric Anxiety Inventory)
Timepoint [3] 304159 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [1] 340817 0
Pain (Visual Analogue Scale), this outcome is primary.
Timepoint [1] 340817 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [2] 341113 0
Lower body strength (30-second chair stand test), this outcome is primary
Timepoint [2] 341113 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [3] 341114 0
Arm strength (Grip strength test), this outcome is primary
Timepoint [3] 341114 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [4] 341115 0
Balance (Functional reach test), this outcome is primary.
Timepoint [4] 341115 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [5] 341116 0
Endurance (2-minute walk test), this outcome is primary
Timepoint [5] 341116 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [6] 341117 0
The feasibility of this study, which included percentage of recruitment, intervention acceptability, participant retention, data missing, adherence, and intervention fidelity, theses are also primary
Timepoint [6] 341117 0
After the intervention

Eligibility
Key inclusion criteria
1. office workers (administtrative and academic staff) aged 55 years and over
2. Independently ambulant
3. Engaging in less than 60 minutes of accumulated moderate intensity physical activity (e.g. brisk walking, bicycling, Yoga) per week
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Serious health issues that prevent you becoming more physically active (measured by the Physical Activity Readiness Questionnaire)
2. Significant vision impairment (not able to see and follow instruction)
3. Tai Chi experience in the past one year (obtaining Tai Chi exercise for any reason)
4. Cannot endure Tai Chi exercise (moderate intensity activity) for 45 minutes three times per week

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 envelopes were used to randomize participants to either the intervention or the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
A total of 40 participants (i.e. 20 participants in each group) will be recruited. This proposed sample size is considered adequate for a pilot RCT study for standardised effect sizes that range from small to medium

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/01/2017
Date of last participant enrolment
Anticipated
Actual
28/06/2017
Date of last data collection
Anticipated
Actual
5/10/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298084 0
University
Name [1] 298084 0
Griffith University HDR financial support
Country [1] 298084 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan campus Griffith University, 170 Kessels Road, NATHAN QLD 4111
Country
Australia
Secondary sponsor category [1] 297163 0
None
Name [1] 297163 0
Address [1] 297163 0
Country [1] 297163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299107 0
Griffith University Human Research Ethics
Ethics committee address [1] 299107 0
Ethics committee country [1] 299107 0
Australia
Date submitted for ethics approval [1] 299107 0
08/11/2016
Approval date [1] 299107 0
22/11/2016
Ethics approval number [1] 299107 0
Griffith University Reference Number: 2016/872

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79310 0
Prof Wendy Moyle
Address 79310 0
Menzies Health Institute Queensland, Nathan campus, Griffith University, 170 Kessels Road QLD 4111, Australia
Country 79310 0
Australia
Phone 79310 0
+61 (07) 373 55526
Fax 79310 0
Email 79310 0
w.moyle@griffith.edu.au
Contact person for public queries
Name 79311 0
Meiling Qi
Address 79311 0
School of Nursing and Midwifery, Health Science, N48, Nathan campus, Griffith University, 170 Kessels Road QLD 4111, Australia
Country 79311 0
Australia
Phone 79311 0
+61 449895159
Fax 79311 0
Email 79311 0
meiling.qi@griffithuni.edu.au
Contact person for scientific queries
Name 79312 0
Meiling Qi
Address 79312 0
School of Nursing and Midwifery, Health Science, N48, Nathan campus, Griffith University, 170 Kessels Road QLD 4111, Australia
Country 79312 0
Australia
Phone 79312 0
+61 449895159
Fax 79312 0
Email 79312 0
meiling.qi@griffithuni.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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Tai Chi Combined with Theraband Training on Physical Fitness, Psychological Well-being, and Pain in Older Sedentary Office Workers: A Pilot Randomized Controlled Trial.2019https://dx.doi.org/10.1097/TGR.0000000000000244
N.B. These documents automatically identified may not have been verified by the study sponsor.