Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001070820
Ethics application status
Approved
Date submitted
30/06/2021
Date registered
13/08/2021
Date last updated
22/12/2021
Date data sharing statement initially provided
13/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Safety and Feasibility of a Judo-Based Exercise Program for Fear of Falling in Older Adults
Scientific title
Evaluating the Safety and Feasibility of a Judo-Based Exercise Program for Fear of Falling in Older Adults
Secondary ID [1] 304667 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of Falls 322624 0
Condition category
Condition code
Injuries and Accidents 320245 320245 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot and feasibility study including community-dwelling older adults aged 65 years and older who will participate in a supervised judo-based exercise program conducted twice per week (60mins per session) over 8 weeks.

The program will include 20 participants (2 groups of 10 participants each to ensure adequate supervision and participant safety) and focus on low-intensity balance exercises and falling safely techniques. The sessions will be delivered by Adelaide University Judo Club (AUJC) instructors.

Safety and feasibility will be assessed weekly by monitoring participants' adherence, any issues that may arise, and adverse events. In addition, a post-evaluation questionnaire will be administered to collect participants' feedback on the pilot intervention.
Intervention code [1] 321028 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328107 0
Safety using a standard Adverse Events Form.
Timepoint [1] 328107 0
Recorded weekly throughout the 8 week intervention.
Primary outcome [2] 328304 0
Feasibility using weekly notes on participants' compliance, any arising issues, and a study-specific post-evaluation questionnaire to collect participants' feedback on the pilot intervention.
Timepoint [2] 328304 0
Compliance notes recorded weekly throughout the 8 week intervention, and study-specific questionnaire post intervention.
Secondary outcome [1] 397651 0
Fear of Falling using the Falls Efficacy Scale
Timepoint [1] 397651 0
Pre (week 0: baseline/prior to intervention) and Post (week 9: after 8 week intervention)
Secondary outcome [2] 398484 0
Quality of Life using the SF-36
Timepoint [2] 398484 0
Pre (week 0: baseline/prior to intervention) and Post (week 9: after 8 week intervention)
Secondary outcome [3] 398485 0
Balance using the Berg Balance Scale
Timepoint [3] 398485 0
Pre (week 0: baseline/prior to intervention) and Post (week 9: after 8 week intervention)
Secondary outcome [4] 398486 0
Physical Performance using Timed Up & Go and Short Physical Performance Battery
Timepoint [4] 398486 0
Pre (week 0: baseline/prior to intervention) and Post (week 9: after 8 week intervention)
Secondary outcome [5] 398487 0
Physical Activity using an Accelerometer
Timepoint [5] 398487 0
Pre (week 0: baseline/prior to intervention) and Post (week 9: after 8 week intervention)

Eligibility
Key inclusion criteria
Participants 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
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants 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
Completed
Date of first participant enrolment
Anticipated
30/08/2021
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
14/09/2021
Date of last data collection
Anticipated
Actual
18/11/2021
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 309033 0
Government body
Name [1] 309033 0
Government of South Australia - Office for Recreation Sport and Racing (ORSR)
Country [1] 309033 0
Australia
Funding source category [2] 309034 0
Government body
Name [2] 309034 0
City of West Torrens Council
Country [2] 309034 0
Australia
Primary sponsor type
Other Collaborative groups
Name
University of Adelaide Judo Club
Address
Thebarton Training Centre
Bldg 5, Winwood Street
Thebarton, SA 5031
Country
Australia
Secondary sponsor category [1] 309970 0
University
Name [1] 309970 0
University of Adelaide
Address [1] 309970 0
Basil Hetzel Institute for Translational Health Research
Discipline of Medicine
37a Woodville Road
Woodville South, SA 5011
Country [1] 309970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308912 0
University of Adelaide Human Research Ethics Commitee
Ethics committee address [1] 308912 0
Ethics committee country [1] 308912 0
Australia
Date submitted for ethics approval [1] 308912 0
07/04/2021
Approval date [1] 308912 0
26/05/2021
Ethics approval number [1] 308912 0
H-2021_078

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

Contacts
Principal investigator
Name 112318 0
Dr Agathe Daria Jadczak
Address 112318 0
Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011
Country 112318 0
Australia
Phone 112318 0
+61 8 8133 4012
Fax 112318 0
Email 112318 0
[email protected]
Contact person for public queries
Name 112319 0
Agathe Daria Jadczak
Address 112319 0
Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011
Country 112319 0
Australia
Phone 112319 0
+61 8 8133 4012
Fax 112319 0
Email 112319 0
[email protected]
Contact person for scientific queries
Name 112320 0
Agathe Daria Jadczak
Address 112320 0
Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011
Country 112320 0
Australia
Phone 112320 0
+61 8 8133 4012
Fax 112320 0
Email 112320 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.