Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000911796
Ethics application status
Approved
Date submitted
19/06/2021
Date registered
27/06/2022
Date last updated
19/09/2023
Date data sharing statement initially provided
27/06/2022
Date results information initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
ReacStep Study: Step Training program for improving fall risk and cognition in older adults
Scientific title
Effects of a 6-week step training program on fall risk and cognition in older adults: A blinded randomised controlled trial
Secondary ID [1] 304519 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cognition 322383 0
Falls 326797 0
Condition category
Condition code
Neurological 320045 320045 0 0
Dementias
Musculoskeletal 324012 324012 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will undertake a 6 week supervised step training session consisting of warm-up exercises, reactive step training (with an added cognitive component) and volitional step training, once a week lasting 45 minutes each session. Within this 6 week training period, they will also complete a home-based lower limb strength training twice per week, lasting 15 minutes each session. The step training will be supervised by (an exercise physiologist) and the intensity will be tailored according to individual capacity. Reactive step training will involve learning rapid and elevated reactive stepping using a manual tether-release technique. A 7-14cm height foam block will be used to train elevated and rapid stepping responses. The cognitive component of it involves the participant memorising and reciting words in order. The volitional step training will involve stepping on to a slippery plastic sheet with progressively lengthened slip targets. An attendance checklist will be used to monitor attendance to training sessions.

The home-based lower limb strength training will be conducted at home (twice/week). It involves the warm-up of quad stretch, hamstring stretch and hip flexor stretch (1 set of 20 seconds), and the exercises high knee with resistance band, standing hip abductions with resistance band, standing glute kickbacks with resistance band, and squats with resistance band (1 set of 20 repetitions). Participants will receive a link to a home exercise video (exercise demonstrations for their training program). Exercise diaries and weekly SMS survey will be used to monitor adherence to training program.
Intervention code [1] 320874 0
Prevention
Intervention code [2] 320875 0
Rehabilitation
Comparator / control treatment
The control group will only complete the home-based lower limb strength training, and will complete the same exercises, intensity and frequency as the intervention group. Exercise diaries and weekly SMS survey will be used to monitor adherence to training program.
Control group
Active

Outcomes
Primary outcome [1] 327927 0
Rate of falls following induced trip and slip in laboratory setting (Okubo et al., 2019)
Timepoint [1] 327927 0
Week 9 (2 weeks after the completion of a 6-week intervention)
Secondary outcome [1] 397036 0
Executive function assessed by the Trail making test
Timepoint [1] 397036 0
Week 8 (following a 6-week intervention)
Secondary outcome [2] 397037 0
Processing Speed assessed by the Symbol Digits Modalities Test
Timepoint [2] 397037 0
Week 8 (following a 6-week intervention)
Secondary outcome [3] 411200 0
Short term memory assessed by the Hopkins Verbal Learning Test
Timepoint [3] 411200 0
Week 8 (following a 6-week intervention)
Secondary outcome [4] 411201 0
Dual-Task Ability assessed by calculating while walking
Timepoint [4] 411201 0
Week 8 (following a 6-week intervention)
Secondary outcome [5] 411202 0
Maximum step length
Timepoint [5] 411202 0
Week 8 (following a 6-week intervention)
Secondary outcome [6] 411231 0
Strength measured by isometric knee extension strength while seated
Timepoint [6] 411231 0
Week 8 (following a 6-week intervention)
Secondary outcome [7] 411232 0
Static balance assessed by postural sway test
Timepoint [7] 411232 0
Week 8 (following a 6-week intervention)
Secondary outcome [8] 411233 0
Simple gait speed assessed by an electric walkway
Timepoint [8] 411233 0
Week 8 (following a 6-week intervention)
Secondary outcome [9] 411234 0
Long term memory assessed by delayed recall
Timepoint [9] 411234 0
Week 8 (following a 6-week intervention)
Secondary outcome [10] 412338 0
Falls, trips and slips in daily life prospectively recorded using a falls diary and reported weekly via SMS surveys
Timepoint [10] 412338 0
For the 12-month follow-up period (week 1 to week 52)
Secondary outcome [11] 412339 0
Choice Stepping Reaction Time test
Timepoint [11] 412339 0
Week 8 (following a 6-week intervention)

Eligibility
Key inclusion criteria
• Living independently in the community
• Able to walk 50 metres without mobility aid or resting
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Diagnosed neurological diseases (Parkinson’s disease, multiple sclerosis and dementia)
• Existing conditions that prevent exercise (e.g. severe pain, heel ulcers, exercise intolerance), or advised by a medical practitioner not to exercise
• History of lower limb, pelvis or vertebral fracture(s) or lower limb joint replacement(s) in the past 6 months

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)
Allocation will be concealed using a randomisation software for clinical trials (Blinders, NeuRA). Randomisation will be conducted after the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using the randomisation software Blinders with random block sizes and 1:1 allocation ratio.
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
Participant characteristics will be compared between the intervention and control groups using the independent-sample t test. The physical and cognitive measurements at post-intervention will be compared between the groups using the analysis of covariance (ANCOVA) while adjusting for any baseline differences (e.g. age, falls risk). Poisson regression with number of falls as a dependent variable, group allocation as an independent variable will be used to compare the rate of falls between the groups. P < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/02/2023
Actual
21/10/2022
Date of last data collection
Anticipated
1/02/2024
Actual
23/12/2022
Sample size
Target
90
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19765 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 34407 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 308883 0
Other
Name [1] 308883 0
Neuroscience Research Australia
Country [1] 308883 0
Australia
Funding source category [2] 309094 0
University
Name [2] 309094 0
University of New South Wales
Country [2] 309094 0
Australia
Funding source category [3] 309095 0
Hospital
Name [3] 309095 0
Prince of Wales Hospital
Country [3] 309095 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 310037 0
University
Name [1] 310037 0
University of New South Wales
Address [1] 310037 0
UNSW Sydney, Sydney NSW 2052
Country [1] 310037 0
Australia
Secondary sponsor category [2] 310038 0
Hospital
Name [2] 310038 0
Prince of Wales Hospital
Address [2] 310038 0
320-346 Barker St, Randwick NSW 2031
Country [2] 310038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308788 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 308788 0
UNSW Sydney, NSW 2052
Ethics committee country [1] 308788 0
Australia
Date submitted for ethics approval [1] 308788 0
03/05/2021
Approval date [1] 308788 0
11/06/2021
Ethics approval number [1] 308788 0
HC210350

Summary
Brief summary
Decline in cognition and physical function often occurs simultaneously and increase falls risk in older people. Previous research has shown that step training reduces falls risk as well as improving cognition. Previous research has also shown that combining motor and cognitive training would induce greater cognitive improvements than individual motor or cognitive training. Therefore, we have created ReacStep, a novel step training program with an added cognitive component. it requires minimal equipment and can be individually tailored to older adults with a range of physical functional levels. This trial will examine the effects of the ReacStep program on fall risk and cognitive function in older adults. We hypothesise the the ReacStep program will improve fall risk and cognition in healthy older adults. If this study is successful at improving fall risk and cognition, it will provide a basis for a larger clinical trial and a feasible solution for preventing falls and dementia in older adults, and can be a new training program that health professionals can use in their practice.




Trial website
Expression of Interest
https://data.neura.edu.au/surveys/?s=HHL4DKP4EX
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111886 0
Dr Yoshiro Okubo
Address 111886 0
Neuroscience Research Australia, 139 Barker Street, Randwick, NSW 2031
Country 111886 0
Australia
Phone 111886 0
+61 2 9399 1065
Fax 111886 0
Email 111886 0
[email protected]
Contact person for public queries
Name 111887 0
Dr Yoshiro Okubo
Address 111887 0
Neuroscience Research Australia, 139 Barker Street, Randwick, NSW 2031
Country 111887 0
Australia
Phone 111887 0
+61 2 9399 1065
Fax 111887 0
Email 111887 0
[email protected]
Contact person for scientific queries
Name 111888 0
Dr Yoshiro Okubo
Address 111888 0
Neuroscience Research Australia, 139 Barker Street, Randwick, NSW 2031
Country 111888 0
Australia
Phone 111888 0
+61 2 9399 1065
Fax 111888 0
Email 111888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable electronic data may be shared when appropriate. Individual participant data of published results may be shared when requested by the journal. Other individual participant data may be shared when appropriate request is made.
When will data be available (start and end dates)?
Following publication of the study results for up to 5 years.
Available to whom?
An investigator who propose worthy use and an appropriate analysis plan and have an ethical approval may contact the chief investigator who will assess whether the secondary analysis plan is in line with the current ethics approval and seek ethics amendments accordingly.
Available for what types of analyses?
A secondary analysis plan for the purpose of health promotion will be considered.
How or where can data be obtained?
Access is subject to approvals by the chief investigator ([email protected]) and ethics committee.


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.