Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000563561p
Ethics application status
Not yet submitted
Date submitted
20/04/2024
Date registered
3/05/2024
Date last updated
3/05/2024
Date data sharing statement initially provided
3/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a VR-based Balance Training Program on Exercise Adherence, Balance, and Mobility of Older Adults: A Randomized Controlled Trial
Scientific title
Efficacy of a VR-based Balance Training Program on Exercise Adherence, Balance, and Mobility of Older Adults: A Randomized Controlled Trial
Secondary ID [1] 312006 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 333615 0
Impaired balance 333616 0
Mobility difficulty 333646 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330304 330304 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a virtual reality-based balance exercise (VR-BEx) program designed for healthy older adults. VR-BEx contains 5 exergames that are designed to address different fall risk factors such as balance, reaction time, and lower body strength. The exergames will be projected on an LED TV position 3 meters in front of the participant. The exercise tasks featured in the exergames include tandem stance, single leg stance, lateral weight-transfer, reaction stepping, and squat. The exercise task will be performed 10 times at each trial and the exergame will be played twice. Each exergame will be played for 5 minutes interspersed with a 2 minute rest interval. The difficulty setting of each exergame will be adjusted to ensure that the exercise task is performed at a moderate difficulty level (i.e. 4 - 6 of the 10-point Perceived Difficulty Rating scale). The intervention will be implemented for 30 - 40 minutes three times a week for 6 months at the Selwyn Village (i.e., aged care facility) and Exercise Science Building of the University of Auckland. A research assistant will supervise the intervention in-person for the first 3 months to help the participant familiarize with the system and how to change the game settings (e.g., difficulty level). The participant will perform the balance exergame program unsupervised in the remainder of the study. VR-BEx will automatically record the scores and relevant data (e.g., date, exercise duration) each time the participant uses the exergame system.
Intervention code [1] 328461 0
Prevention
Comparator / control treatment
Participants in the control group will be prescribed with an individualized fall prevention exercise program by a physiotherapist or clinical exercise physiologist that consists of balance and strengthening exercises. The individualized exercise prescription will be based on the baseline functional tests (e.g., Short Physical Performance Battery) to determine which risk factor (e.g., balance, lower extremity strength) needs to be addressed. Examples of balance exercises are 10 - 30 seconds tandem stance while 5 - 10 sit to stands is an example of a strengthening exercise. A research assistant will teach the exercises to the study participant during the first week and the participant will be given an exercise log book to help them monitor their performance.The exercise program will be unsupervised but the participant will be encouraged to perform the exercises for 30-40 minutes, three times a week for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 338046 0
Exercise Adherence
Timepoint [1] 338046 0
Weekly during the 6 month study period
Primary outcome [2] 338047 0
Falls
Timepoint [2] 338047 0
Monthly during the 6 month study period
Primary outcome [3] 338048 0
Balance
Timepoint [3] 338048 0
Baseline, 3rd month, and 6th month post-commencement of the intervention by the participant
Secondary outcome [1] 434302 0
Mobility
Timepoint [1] 434302 0
Baseline, 3rd month, and 6th month post-commencement of the intervention by the participant
Secondary outcome [2] 434303 0
Fear of falling
Timepoint [2] 434303 0
Baseline, 3rd month, and 6th month post-commencement of the intervention by the participant
Secondary outcome [3] 434518 0
Quality of life
Timepoint [3] 434518 0
Baseline, 3rd month, and 6th month post-commencement of the intervention by the participant
Secondary outcome [4] 434519 0
Acceptability of intervention
Timepoint [4] 434519 0
Baseline, 3rd month, and 6th month post-commencement of the intervention by the participant

Eligibility
Key inclusion criteria
Apparently healthy older adults living in the community and aged care facilities that can walk unaided and make informed decisions independently
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Older adults who had a fall event in the past 6 months or with moderate to severe cognitive impairment or with moderate to severe auditory or visual impairment or with uncontrolled hypertension or with vestibular dysfunction.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation using computer-generated random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A logistic regression model will be used to analyze the number of participants who had fall events during the study period. A two-way analysis of variance (i.e., group x time) will be employed to determine if significant differences exist in the quantitative outcome measures (e.g., limits of stability).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 26266 0
New Zealand
State/province [1] 26266 0
Auckland

Funding & Sponsors
Funding source category [1] 316351 0
Charities/Societies/Foundations
Name [1] 316351 0
Selwyn Foundation
Country [1] 316351 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318537 0
None
Name [1] 318537 0
Address [1] 318537 0
Country [1] 318537 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315162 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315162 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 315162 0
New Zealand
Date submitted for ethics approval [1] 315162 0
13/05/2024
Approval date [1] 315162 0
Ethics approval number [1] 315162 0

Summary
Brief summary
A meta-analysis by Sherrington and colleagues (2017) provided strong evidence that exercise and balance training reduced fall events. Unfortunately, supervised exercise training programs are not viable in the long run due to limited resources and high cost. A possible solution to address low adherence and unaddressed fall-risk factors is to provide a multi-component rehabilitation program that utilizes gamified exercise tasks (i.e., exergames) through virtual reality. Our group developed a VR-based balance training program that had been deemed acceptable and tolerable by a small sample of older adults. The proposed clinical trial aims to compare the exercise adherence, balance, and mobility of older adults enrolled in a balance exergame program (i.e., intervention group) and traditional balance training program (i.e., control group). The intervention group is expected to report greater exercise adherence, balance outcome measures, and mobility outcome measures than the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133866 0
Dr Yanxin Zhang
Address 133866 0
Department of Exercise Sciences, University of Auckland, Building 907, End of Suiter Street, Newmarket, Auckland
Country 133866 0
New Zealand
Phone 133866 0
+6493737599
Fax 133866 0
Email 133866 0
yanxin.zhang@auckland.ac.nz
Contact person for public queries
Name 133867 0
Peter Fermin Dajime
Address 133867 0
Department of Exercise Sciences, University of Auckland, Building 907, End of Suiter Street, Newmarket, Auckland
Country 133867 0
New Zealand
Phone 133867 0
+64 272372999
Fax 133867 0
Email 133867 0
pdaj783@aucklanduni.ac.nz
Contact person for scientific queries
Name 133868 0
Peter Fermin Dajime
Address 133868 0
Department of Exercise Sciences, University of Auckland, Building 907, End of Suiter Street, Newmarket, Auckland
Country 133868 0
New Zealand
Phone 133868 0
+64 272372999
Fax 133868 0
Email 133868 0
pdaj783@aucklanduni.ac.nz

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.