Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000619549
Ethics application status
Approved
Date submitted
30/04/2024
Date registered
14/05/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Translation of Dynamic-Balance-for-Life® program to up-skill the aged care allied health workforce to teach older adults how to land safely from a fall
Scientific title
Efficacy of the Dynamic-Balance-for-Life® program to up-skill the aged care allied health workforce to teach older adults how to land safely from a fall
Secondary ID [1] 312052 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of Falls 333662 0
Condition category
Condition code
Injuries and Accidents 330350 330350 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to upskill Allied Health Professionals and Judo coaches to provide an 8-week Judo-based exercise program to older adults to teach them the core skills required to land safely from a controlled fall. In addition, this project will evaluate how effective the 8-week Judo based exercise program is in improving safe-landing skills in community-dwelling older adults aged 65 Years and older.

Train-the-Trainer Intervention:
The Train-the-Trainer program will include 10 Allied Health Professionals (i.e. Physiotherapists) working in Aged Care with no experience in Judo, and 10 experienced and accredited Judo coaches with no experience working with older adults.
Allied Health Professionals (i.e. Physiotherapists) will attend a) a 2-day workshop with the focus being on teaching safe landing skills followed by attending b) the 8-week Judo-based exercise program as part of the pre-post study to gain practical experience.
Judo coaches will also attend a) a 2-day workshop but with the focus on working and training with older adults followed by attending b) the 8-week Judo based exercise program as part of the pre-post study to gain practical experience.
Both, the 2-day workshop as well as the 8-week Judo-based exercise program will be delivered at the Adelaide University Judo Club (AUJC) facilities in Thebarton, Adelaide, South Australia, by research staff specialised in frailty and healthy ageing and Judo Coaches with experience in the intervention and working with older adults.
Elements of the Train-the-Trainer Intervention will include modules on physiology of ageing, potential risks when working with older adults, balance, strength and mobility exercises, as well as a practical introduction to landing safely in four different directions, and the difference from Sport Judo.

8-Week Judo-Based Exercise Program:
The 8-week Judo based exercise program will include 40 community-dwelling older people aged 65 years and older (10 per exercise group to ensure adequate supervision and participant safety).
The Judo-based exercise program will be conducted at the AUJC facilities in Thebarton, Adelaide. The program will include safe-landing techniques (ukemi) in four different directions including backwards, sideways (left and right), flat forward and rolling forward direction using a micro-progression approach, as well as a mix of strength, mobility and balance exercises.
The program will have two supervised 60-minute group exercise sessions per week for 8 weeks. Supervision will be provided by an experienced team of Judo coaches from the AUJC, ensuring a 4:1 participant-instructor supervision.
All exercises will progressively increase in intensity and complexity to achieve an intensity of ‘somewhat hard’ (12-15) on the Borg scale for each participant. The Borg Scale will be collected after every session to ensure optimal intensity.

Adherence will be monitored using attendance checklists.
Intervention code [1] 328497 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338111 0
Safe Landing Skills
Timepoint [1] 338111 0
Pre and Post 8-week Judo-based program
Primary outcome [2] 338112 0
Trainers' confidence and skills levels in teaching safe landing techniques to older adults. This will be assessed as a composite outcome.
Timepoint [2] 338112 0
Pre and post 2-day workshop and post 8-week Judo-based program
Secondary outcome [1] 434569 0
Falls and frailty risk
Timepoint [1] 434569 0
Pre and Post 8-week Judo-based program
Secondary outcome [2] 434724 0
Strength
Timepoint [2] 434724 0
Pre and Post 8-week Judo-based program
Secondary outcome [3] 434725 0
Mobility
Timepoint [3] 434725 0
Pre and Post 8-week Judo-based program
Secondary outcome [4] 434726 0
Body Composition
Timepoint [4] 434726 0
Pre and Post 8-week Judo-based program
Secondary outcome [5] 434727 0
Fall-related health literacy
Timepoint [5] 434727 0
Pre and Post 8-week Judo-based program
Secondary outcome [6] 434728 0
Personal capacity and health
Timepoint [6] 434728 0
Pre and Post 8-week Judo-based program
Secondary outcome [7] 434729 0
Fear of falling
Timepoint [7] 434729 0
Pre and Post 8-week Judo-based program
Secondary outcome [8] 434730 0
Older adults' confidence
Timepoint [8] 434730 0
Pre and Post 8-week Judo-based program
Secondary outcome [9] 434731 0
Quality of life
Timepoint [9] 434731 0
Pre and Post 8-week Judo-based program
Secondary outcome [10] 434732 0
Activity levels
Timepoint [10] 434732 0
Pre and Post 8-week Judo-based program

Eligibility
Key inclusion criteria
Judo coaches must have a first degree black-belt (shodan), 2 years’ experience coaching beginners and a CAF (Coaching Accreditation Framework) Judo Assistant Coach certification as a minimum (no age requirement), and no experience working with older adults.

Allied Health Professionals (i.e. physiotherapists, exercise physiologists or occupational therapists, no age requirement) with an appropriate tertiary qualification and at least 2 years’ experience working with older adults, but no Judo experience.

Older adults will be eligible if they are aged 65 years and older, healthy, community-dwelling, able to walk unsupported for everyday tasks, and with no diagnosed illnesses/conditions that would prevent them from exercising.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Older adults will be excluded if they had been advised against physical exercise by their physician, had suffered from congestive heart failure, felt chest pain, dizziness or angina during exercise, had uncontrolled high blood pressure, severe osteoporosis or atlantoaxial instability.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
1/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316414 0
Charities/Societies/Foundations
Name [1] 316414 0
The Hospital Research Foundation
Country [1] 316414 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Adelaide University Judo Club
Address
Country
Australia
Secondary sponsor category [1] 318582 0
University
Name [1] 318582 0
University of Adelaide
Address [1] 318582 0
Country [1] 318582 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315209 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 315209 0
Ethics committee country [1] 315209 0
Australia
Date submitted for ethics approval [1] 315209 0
05/02/2024
Approval date [1] 315209 0
26/04/2024
Ethics approval number [1] 315209 0
H-2024-057

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

Contacts
Principal investigator
Name 133986 0
Dr Agathe Daria Jadczak
Address 133986 0
Basil Hetzel Institute for Translational Health Research, 37a Woodville Road, Woodville South, South Australia 5011
Country 133986 0
Australia
Phone 133986 0
+61 8 8133 4012
Fax 133986 0
Email 133986 0
[email protected]
Contact person for public queries
Name 133987 0
Agathe Daria Jadczak
Address 133987 0
Basil Hetzel Institute for Translational Health Research, 37a Woodville Road, Woodville South, South Australia 5011
Country 133987 0
Australia
Phone 133987 0
+61 8 8133 4012
Fax 133987 0
Email 133987 0
[email protected]
Contact person for scientific queries
Name 133988 0
Agathe Daria Jadczak
Address 133988 0
Basil Hetzel Institute for Translational Health Research, 37a Woodville Road, Woodville South, South Australia 5011
Country 133988 0
Australia
Phone 133988 0
+61 8 8133 4012
Fax 133988 0
Email 133988 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.