Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000479505p
Ethics application status
Submitted, not yet approved
Date submitted
22/03/2024
Date registered
18/04/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
18/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of Mau rakau exercises among people with shoulder osteoarthritis.
Scientific title
Investigating the effects of Mau rakau exercises (mahi a tinana) among people (tangata) 55 years and over with shoulder osteoarthritis.
Secondary ID [1] 311800 0
E8016: Walter - HRC Health Delivery Research Activation Grant 23/993/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glenohumeral osteoarthritis 333316 0
Condition category
Condition code
Musculoskeletal 330002 330002 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 330142 330142 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Mau Rakau exercise programme will be developed and led by a proficient Maori Taiaha teacher from the Te Whare Tu Taua o Waitaha.

The Mau Rakau exercise programme will be designed to target the muscles performing shoulder rotations, abduction, adduction, flexion, extension, and scapular retraction. All shoulder movements of internal/external rotation, abduction/adduction, flexion/extension will be performed in the Mau Rakau exercise programme. The participants will hold a Rakau in their hands and perform a low intensity starting warmup and then perform a set of exercises with progressive intensity. The exercises will start with minimal intensity and the intensity will increase every two weeks. The exercise intensity will be subjectively assessed using the Borg's modified RPE scale.

All the participants who meet the eligibility criteria will need to attend an eight-week Mau Rakau exercise programme. Every week the participants will attend three 45-minute sessions on alternative days to provide a day’s rest between sessions. Two supervised group sessions per week at the University of Canterbury Christchurch campus and one unsupervised home-based session. A group of 10 participants will be monitored by one research assistant.

Each session will run for approximately 45 minutes. Each week’s day one and day five session will be supervised and conducted at the University of Canterbury Christchurch campus. The day three session will be conducted and supervised online with the participants performing the exercises at their home.

During each session, the lead research assistant will record attendance of the participants to monitor adherence to the programme. During each session, participants will be provided manual guidance, verbal encouragement, and motivation by the leading research assistant.

Every week participants will be provided an instructional video, and they will be required to record their exercise programme adherence in a logbook. In the logbook there will be a visual analog pain scale (VAS) on which the participants will be required to subjectively score their pain before and after each session.

A standard Rakau will be given to each participant to perform the exercises and take home.
The exercise intensity will be progressively increased every 2 weeks. If any participant reports excessive pain during the session, they will be immediately referred to a medical practitioner. If any participant reports any discomfort in doing the exercises, then individual adaptations and exercise regressions will be made as required.

Assessment of the outcome variables will be performed at baseline and at the end of every second week for eight weeks.
Intervention code [1] 328247 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337757 0
Mau Rakau exercise programme adherence
Timepoint [1] 337757 0
Assessment of the exercise adherence will be performed at every session.
Primary outcome [2] 337894 0
Shoulder pain response
Timepoint [2] 337894 0
Assessment of pain responses will be conducted before and after every session.
This will be recorded when they perform both the in-home exercises and supervised sessions.
Secondary outcome [1] 433188 0
Kinematic changes to the shoulder joint's active Range of Motion (ROM)
Timepoint [1] 433188 0
At baseline and at the end of every 2 weeks for up to 8 weeks post-enrolment.
Secondary outcome [2] 433189 0
Kinetic changes to the shoulder joint's isometric muscle strength.
Timepoint [2] 433189 0
At baseline and at the end of every 2 weeks for up to 8 weeks post-enrolment.
Secondary outcome [3] 433613 0
Changes to the self-reported shoulder function
Timepoint [3] 433613 0
At baseline and at the end of every 2 weeks for up to 8 weeks post-enrolment.
Secondary outcome [4] 433615 0
Changes to the self-reported shoulder function quality.
Timepoint [4] 433615 0
At baseline and at the end of every 2 weeks for up to 8 weeks post-enrolment.
Secondary outcome [5] 433617 0
Self-reported quality of life
Timepoint [5] 433617 0
At baseline and at the end of every 2 weeks for up to 8 weeks post-enrolment.

Eligibility
Key inclusion criteria
1.Patients 55 years and over
2.Must have moderate to severe primary glenohumeral osteoarthritis.
3.Ability to stand and walk unsupported.
4.Ability to hold the Mau Rakau in both hands.
5.Ability to give consent to participate.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1.Previous or current upper limb fractures
2.Scheduled upper limb surgery in the next 6 months.
3.Diagnosed as another type of glenohumeral arthritis.
4.Existing cancer diagnosis and undergoing cancer treatment.
5.Inability to give consent to participate.
6.Regular participation in Mau Rakau mahi a tinana in the previous 6 months.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26212 0
New Zealand
State/province [1] 26212 0
Canterbury

Funding & Sponsors
Funding source category [1] 316135 0
Government body
Name [1] 316135 0
Health Research Council of New Zealand
Country [1] 316135 0
New Zealand
Funding source category [2] 316136 0
University
Name [2] 316136 0
University of Canterbury
Country [2] 316136 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 318310 0
University
Name [1] 318310 0
University of Canterbury
Address [1] 318310 0
Country [1] 318310 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314961 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314961 0
Ethics committee country [1] 314961 0
New Zealand
Date submitted for ethics approval [1] 314961 0
23/07/2024
Approval date [1] 314961 0
Ethics approval number [1] 314961 0

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

Contacts
Principal investigator
Name 133262 0
Dr Sibi Walter
Address 133262 0
Faculty of Health, University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch 8042
Country 133262 0
New Zealand
Phone 133262 0
+64 3 364 3443
Fax 133262 0
Email 133262 0
[email protected]
Contact person for public queries
Name 133263 0
Sibi Walter
Address 133263 0
Faculty of Health, University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch 8042
Country 133263 0
New Zealand
Phone 133263 0
+64 3 364 3443
Fax 133263 0
Email 133263 0
[email protected]
Contact person for scientific queries
Name 133264 0
Sibi Walter
Address 133264 0
Faculty of Health, University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch 8042
Country 133264 0
New Zealand
Phone 133264 0
+64 3 364 3443
Fax 133264 0
Email 133264 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?

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.