Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000035123p
Ethics application status
Submitted, not yet approved
Date submitted
11/12/2018
Date registered
11/01/2019
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Taurite Tu- Development of a strength and balance exercise programme that is engaging and relevant for Maori living in the Dunedin area, that positively affects the impact of falls for Maori.
Scientific title
Taurite Tu- Development of an effective Falls Prevention exercise programme for Maori.
Secondary ID [1] 296849 0
New Zealand Health Research Council Nga Kanohi Kitea full grant 18/800
Universal Trial Number (UTN)
U1111-1225-3000
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk and prevention 310771 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309453 309453 0 0
Physiotherapy
Injuries and Accidents 309454 309454 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Development, delivery and analysis of impact of strength and balance (Taurite Tu) exercise programme for Maori in Otakou takiwa (area):

1.Development of Exercise programme by members of research team based on: a) feedback from Ropu Kaiawhina (guiding group of older Maori advisers)/users of Taurite Tu. b) consultation with independent experts in falls risk and prevention programme research and development, c) evidence based criteria on strength and balance group programmes effective for falls prevention for use in the community d) Maori movement patterns used traditionally for strength and balance.

Examples of types of exercises are based on the Otago Exercise Programme, which is an evidence based programme (https://www.acc.co.nz/assets/injury-prevention/acc1162-otago-exercise-manual.pdf), Steady As You Go, an evidence based community exercise programme, researched by advising experts to Taurite Tu Asso.prof Leigh Hale and Asso. Prof Debra Waters.
(Waters D.L. Hale, L. Robertson, L. Hale, B. Herbison, P. Evaluation of a Peer-Led Falls Prevention Program for Older Adults. Arch Phys Med Rehabil, 2011; 92:1581-1586, Wurzer, B. Waters D.L. Hale, L. Leon de la Barra. Long-term participation in peer-led fall prevention classes predicts lower fall incidence. Arch Phys Med Rehabil, 2014;95:1060-6.). Examples of exercises found in Age Concern Otago, Steady As You Go- Falls Prevention Home Exercise Booklet. Jan 2016. These exercises will also be modified using traditional Maori movement forms used in rehabilitation such as mau rakau and poi.


2. Implementation of programme over 12 weeks-by physiotherapists and trained instructors.
Duration - 45 mins of exercise (with time allowed for lunch afterwards.)
Frequency - once a week
Period - 12 weeks (beginning September 2019-end of November 2019).
Feedback from the participants will be sought throughout the 12 week programme and alterations made to programme as seen necessary.

3. Analysis of Data:
-Comparative analysis of data collected from falls risk assessment tools and qualitative feedback from interviews, prior and following implementation of Taurite Tu exercise programme.
Intervention code [1] 313137 0
Prevention
Comparator / control treatment
No Control Group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308410 0
Development of an engaging balance and strengthening exercise programme for Maori.
Timepoint [1] 308410 0
At the end of the 18 month project an effective and engaging balance and strengthening exercise programme will be developed. This will be measured by attendance records and feedback throughout 3 month programme. It is intended to continue delivery of programme following this 3month trial and continue to measure of attendance of participants for further indication of participation and engagement of Maori.
Secondary outcome [1] 355116 0
Change in falls risk for Maori in Te Runanga o Otakou area. This composite secondary outcome will be assessed prior and following implementation of the programme using (a)Health Quality and Safety Commission Falls Risk Factor Checklist: assesses falls risk with by asking 3 screening questions assessing previous falls, strength and balance. (https://www.hqsc.govt.nz/assets/Falls/PR/008-falls-toolkit-risk-factor-checklist.pdf)
(b) Measurement of physical risk factors for falls:
- Timed Up and Go test,
- 30-second chair stand,
- four stage balance test

(c) Pokare Whakaro Visual Tool (PWVT) to facilitate discussion development of relationship with participants, individual assessment of participants kanohi ki te kanohi, and measure the impact of exercise programme on Hauora.(Hale L, Bryant K.P, Tikao K, Mirfin-Veitch B, Milosavljevic S. Haua Mana : Living unique and enriched lives. A report for the Health Research Council and the Ministry of Health. 2014:1-159. ISBN 978-0-473-27899-1. http://www.health.govt.nz/publication/haua-mana--living-unique-and- enriched-lives)
Timepoint [1] 355116 0
Following participation in 3 month exercise programme

Eligibility
Key inclusion criteria
Inclusion criteria for Participants:
- Maori whakapapa
- 55+ years old,
- Living in Te Runanga o Otakou takiwa.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
- No medical clearance from potential participant GP or primary health provider to participate in exercise program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment: Aim to recruit 30 participants and their whanau (family). This is based on previous research assessing effectiveness of community based falls prevention program in Otago (Wurzer, B. Waters, D.L. Hale, L. Fall related injuries in a cohort of community-dwelling older adults attending peer-led fall, prevention exercise classes J Geriatr Phys Ther. 2016 Jul-Sep;39(3):110-615).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2019
Actual
Date of last participant enrolment
Anticipated
1/09/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21118 0
New Zealand
State/province [1] 21118 0
Otago

Funding & Sponsors
Funding source category [1] 301421 0
Government body
Name [1] 301421 0
New Zealand Health Research Council
Country [1] 301421 0
New Zealand
Primary sponsor type
Other
Name
Te Runanga o Otakou
Address
Te Runanga o Otakou
45 Tamatea Rd
R.D.2 Otakou
Dunedin 9077
Country
New Zealand
Secondary sponsor category [1] 301112 0
None
Name [1] 301112 0
NA
Address [1] 301112 0
NA
Country [1] 301112 0
Other collaborator category [1] 280460 0
University
Name [1] 280460 0
University of Otago School of Physiotherapy
Address [1] 280460 0
325 Great King St,
North Dunedin,
Dunedin 9016
Country [1] 280460 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302154 0
Health And Disability Ethics Committee (HDEC) of New Zealand
Ethics committee address [1] 302154 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 302154 0
New Zealand
Date submitted for ethics approval [1] 302154 0
11/12/2018
Approval date [1] 302154 0
Ethics approval number [1] 302154 0

Summary
Brief summary
Te Runanga o Otakou has identified there is a gap in Fall Prevention services for Maori living in Te Runanga o Otakou takiwa. Evidence demonstrates that Maori do not recover as well from fall related injuries and have higher mortality rates following serious falls compared to non-Maori. Taurite Tu research is in response to this health issue.
Research objectives include: a) creating a relevant and engaging balance and strengthening exercise programme responsive to needs of Maori b) identifying and reducing falls risks for Maori, and c) increasing hauora research capacity within Te Runanga o Otakou.
Kaupapa Maori Research and Participatory Action Research methodologies will apply to this project. Potential health outcomes for Maori living in Te Runanga o Otakou takiwa include increased participation of in balance and strengthening exercise programmes, and decreased falls risk and related costs. An associated outcome is increased hauora research capacity within Te Runanga o Otakou.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89310 0
Ms Katrina Anne Potiki Bryant
Address 89310 0
University of Otago School of Physiotherapy
325 Great King St, North Dunedin, Dunedin 9016
Country 89310 0
New Zealand
Phone 89310 0
+64 21 1140304
Fax 89310 0
Email 89310 0
[email protected]
Contact person for public queries
Name 89311 0
Ms Katrina Anne Potiki Bryant
Address 89311 0
University of Otago School of Physiotherapy
325 Great King St, North Dunedin, Dunedin 9016
Country 89311 0
New Zealand
Phone 89311 0
+64 21 1140304
Fax 89311 0
Email 89311 0
[email protected]
Contact person for scientific queries
Name 89312 0
Ms Katrina Anne Potiki Bryant
Address 89312 0
University of Otago School of Physiotherapy
325 Great King St, North Dunedin, Dunedin 9016
Country 89312 0
New Zealand
Phone 89312 0
+64 21 1140304
Fax 89312 0
Email 89312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23708Ethical approvalEthics ref: 18/NTB/237 Study title: Taurite Tu- Development of Falls Prevention exercise programme for Maori living in Te Runanga o Otakou takiwa/region. https://ethics.health.govt.nz[email protected] none 376563-(Uploaded-17-12-2019-06-08-44)-Study-related document.pdf

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.