Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000138583
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
13/02/2015
Date last updated
10/12/2019
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Standing Tall - a home-based exercise program using mobile technology for preventing falls in older people
Scientific title
Evaluating the effect of a home-based exercise program delivered through mobile technology for preventing falls in older community-dwelling people over 2 years, compared to a health promotion education ‘control’ program. The 'Standing Tall' randomized control trial.
Secondary ID [1] 285970 0
Nil
Universal Trial Number (UTN)
Trial acronym
Standing Tall
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 293908 0
Condition category
Condition code
Injuries and Accidents 294212 294212 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 294213 294213 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of balance training delivered through a tablet computer in people’s homes. Participants will be asked to do the balance exercises unsupervised for at least two hours per week for 2 years. The exercises will be tailored to the participant’s balance abilities for the duration of the trial.

* Dose will gradually increase from 40 min per week (week 1,2), to 60 min (week 3,4), 80 min (week 5,6), 100 min (week 7, 8) and 120 min from week 9 onwards. Participants will be encouraged to undertake at least 120 min per week for the trial duration.
* Intensity of the balance exercises is adjusted as performance improves to ensure that exercises remain challenging. Progression of training intensity is guided by an inbuilt coach based on data from recent training activity.


STUDY PROTOCOL
* Participants will receive a tablet computer with the 'Standing Tall' balance training program and exercise equipment (foam mat, box, exercise mat).
* During an initial home visit (~2 hours), the exercise trainer (exercise physiologist or physiotherapist) will explain to the participant how to use the 'Standing Tall' program. The exercise trainer will perform an initial balance assessment to ensure that the exercises are tailored to the participant's balance abilities and deliver balance training instructions. The exercise trainer will also explain how to use other features of the Standing Tall app; such as scheduling exercises, tracking progress, setting goals, accessing additional information.
* Participants will receive a follow-up home visit at 4 weeks (~1 hour) to ensure safe use and progression of training and discuss any issues related to using the program.
* Participant adherence (training volume, frequency) will be monitored following automatic data transfer to a server, and will be examined weekly. Participants are reminded of their training dose within the app. Participants not engaging in the minimum weekly training dose for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence for the first 6 months.
* Phone support will be available and additional home visits will be offered as needed/requested for the entire duration of the study (i.e. 2 years).
Intervention code [1] 290947 0
Prevention
Comparator / control treatment
Control group participants will receive a health promotion education program focused on health-related information relevant to older adults (e.g. healthy diet, medications), delivered through the tablet computer with weekly fact sheets, in addition to usual care for the entire duration of the study (i.e. 2 years).
Control group
Active

Outcomes
Primary outcome [1] 293998 0
The proportion of fallers in each group: Falls will be monitored with weekly fall diaries through the tablet computer.
Timepoint [1] 293998 0
12 months after baseline assessment
Primary outcome [2] 294033 0
The rate of falling in each group: Falls will be monitored with weekly fall diaries through the tablet computer.
Timepoint [2] 294033 0
12 months after baseline assessment
Secondary outcome [1] 312368 0
The proportion of fallers in each group: Falls will be monitored with weekly fall diaries through the tablet computer.
Timepoint [1] 312368 0
24 months after baseline assessment
Secondary outcome [2] 312369 0
The rate of falling in each group: Falls will be monitored with weekly fall diaries through the tablet computer.
Timepoint [2] 312369 0
24 months after baseline assessment
Secondary outcome [3] 312370 0
Questionnaire measure of concern about falling using the iconographical Falls Efficacy Scale.
Timepoint [3] 312370 0
At baseline and at 6, 12, 18 and 24 months after baseline assessment.
Secondary outcome [4] 312371 0
Clinical measures of balance (postural sway, maximum balance range, coordinated stability test) using the Physiological Profile Assessment.
Timepoint [4] 312371 0
At baseline and at 6 and 12 months (sub-sample of 200 participants)
Secondary outcome [5] 312373 0
Neuropsychological measures of processing speed and executive functioning using the Montreal Cognitive Assessment, Trail making tests and Stroop test.
Timepoint [5] 312373 0
At baseline and at 6 and 12 months (sub-sample of 200 participants)
Secondary outcome [6] 312375 0
Adherence to the intervention as average weekly training dose and total training dose recorded by the tablet computer and monitored following data transfer to server.
Timepoint [6] 312375 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)
Secondary outcome [7] 312378 0
Usability of the intervention is assessed using the System Usability Scale.
Timepoint [7] 312378 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)
Secondary outcome [8] 312380 0
Health care use recorded with monthly diaries through the tablet computer.
Timepoint [8] 312380 0
12 and 24 months after baseline assessment
Secondary outcome [9] 312748 0
Questionnaire measure of quality of life using the European Quality of Life-5 Dimensions and Australian Quality of Life assesment.
Timepoint [9] 312748 0
At baseline and at 6, 12, 18 and 24 months
Secondary outcome [10] 312749 0
Questionnaire measure of physical activity levels using the Incidental and Planned Exercise Questionnaire.
Timepoint [10] 312749 0
At baseline and at 6, 12, 18 and 24 months
Secondary outcome [11] 312750 0
Clinical measures of gait (10m walk test, 1 week daily monitoring using a wearable sensor).
Timepoint [11] 312750 0
At baseline and at 6 and 12 months (sub-sample of 200 participants)
Secondary outcome [12] 312751 0
Clinical measures of stepping using the Choice Stepping Reaction Time tests.
Timepoint [12] 312751 0
At baseline and at 6 and 12 months (sub-sample of 200 participants)
Secondary outcome [13] 312752 0
Adverse events due to system use (e.g. falls) monitored with the weekly diaries through the tablet computer.
Timepoint [13] 312752 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)
Secondary outcome [14] 312805 0
Questionnaire measure of depressive symptoms using Patient Health Questionnaire-9.
Timepoint [14] 312805 0
At baseline and at 6, 12, 18 and 24 months after baseline assessment.
Secondary outcome [15] 312806 0
Functional measures of timed up and go test and sit-to-stand test.
Timepoint [15] 312806 0
At baseline and at 6 and 12 months (sub-sample of 200 participants)
Secondary outcome [16] 312938 0
Enjoyment of the intervention is assessed using the Physical Activity Enjoyment Scale.
Timepoint [16] 312938 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)
Secondary outcome [17] 312939 0
Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale.
Timepoint [17] 312939 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)
Secondary outcome [18] 312940 0
Exercise self-efficacy is assessed using the Exercise Self-Efficacy Scale.
Timepoint [18] 312940 0
6, 12, 18 and 24 months after baseline assessment (intervention group only)

Eligibility
Key inclusion criteria
* 70 years of age or older
* Living in the community
* English-speaking
* Independent in activities of daily living
* Able to walk household distances without the use of a walking aid
* Willingness to give informed consent and comply with the study protocol
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unstable or acute medical condition that precludes exercise participation
* Progressive neurological condition (such as Parkinson’s disease, Multiple Sclerosis, Meniere Disease)
* Cognitively impaired defined as a Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score <8
* Currently participating in a fall prevention program

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)
Potential participants will be screened for eligibility over the phone. Eligible participants will proceed to perform the baseline assessment. Following the baseline assessment, the participants will be randomly allocated to the intervention group or control group using a web-based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined using a computer generated random number schedule. Central randomisation by computer will be used via an external web-based randomisation service. The person performing the randomisation will not be involved in any assessments of this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2015
Actual
17/02/2015
Date of last participant enrolment
Anticipated
15/12/2017
Actual
13/10/2017
Date of last data collection
Anticipated
13/10/2019
Actual
2/11/2019
Sample size
Target
500
Accrual to date
Final
510
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290553 0
Government body
Name [1] 290553 0
National Health and Medical Research Council
Country [1] 290553 0
Australia
Funding source category [2] 290554 0
Charities/Societies/Foundations
Name [2] 290554 0
Gandel Philanthropy
Country [2] 290554 0
Australia
Funding source category [3] 290555 0
Charities/Societies/Foundations
Name [3] 290555 0
NeuRA Foundation
Country [3] 290555 0
Australia
Primary sponsor type
Individual
Name
Dr Kim Delbaere
Address
NeuRA
Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 289247 0
Individual
Name [1] 289247 0
Professor Stephen Lord
Address [1] 289247 0
NeuRA
Barker Street
Randwick NSW 2031
Country [1] 289247 0
Australia
Other collaborator category [1] 278290 0
Individual
Name [1] 278290 0
Assistant Professor GA Rixt Zijlstra
Address [1] 278290 0
Maastricht University
Duboisdomein 30
6229 GT Maastricht
Country [1] 278290 0
Netherlands
Other collaborator category [2] 278291 0
Individual
Name [2] 278291 0
Associate Professor Lindy Clemson
Address [2] 278291 0
University of Sydney
Corner City Road and Butlin Avenue
Camperdown NSW 2050
Country [2] 278291 0
Australia
Other collaborator category [3] 278292 0
Individual
Name [3] 278292 0
Professor Jacqueline Close
Address [3] 278292 0
NeuRA
Barker St
Randwick NSW 2031
Country [3] 278292 0
Australia
Other collaborator category [4] 278294 0
Individual
Name [4] 278294 0
Professor Kirsten Howard
Address [4] 278294 0
Institute for Choice, UniSA Business School
Level 13, 140 Arthur Street
North Sydney NSW 2060
Country [4] 278294 0
Australia
Other collaborator category [5] 278297 0
Individual
Name [5] 278297 0
Trinidad Valenzuela Artaega
Address [5] 278297 0
NeuRA
Barker Street
Randwick NSW 2031
Country [5] 278297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292199 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 292199 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 292199 0
Australia
Date submitted for ethics approval [1] 292199 0
Approval date [1] 292199 0
03/12/2014
Ethics approval number [1] 292199 0
14266

Summary
Brief summary
Accidental falls remain an important problem for older people. Exercise has proven to be the single most effective intervention to reduce falls. However, sustained adherence to these interventions is poor. Our Standing Tall program is designed in line with evidence-based, best-practice principles for fall prevention that will not only aim to improve balance and reduce falls but also has the potential to maximize long-term adherence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54042 0
Dr Kim Delbaere
Address 54042 0
NeuRA
Barker St
Randwick 2031 NSW
Country 54042 0
Australia
Phone 54042 0
+61 2 9399 1066
Fax 54042 0
Email 54042 0
[email protected]
Contact person for public queries
Name 54043 0
Dr Kim Delbaere
Address 54043 0
NeuRA
Barker St
Randwick 2031 NSW
Country 54043 0
Australia
Phone 54043 0
+61 2 9399 1066
Fax 54043 0
Email 54043 0
[email protected]
Contact person for scientific queries
Name 54044 0
Dr Kim Delbaere
Address 54044 0
NeuRA
Barker St
Randwick 2031 NSW
Country 54044 0
Australia
Phone 54044 0
+61 2 9399 1066
Fax 54044 0
Email 54044 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?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
From July 2020; no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator
requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
801Study protocol    367746-(Uploaded-15-12-2018-21-11-24)-Study-related document.pdf
6114Statistical analysis plan  [email protected]
6115Informed consent form  [email protected]
6116Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the effectiveness of a home-based exercise programme delivered through a tablet computer for preventing falls in older community-dwelling people over 2 years: Study protocol for the Standing Tall randomised controlled trial.2015https://dx.doi.org/10.1136/bmjopen-2015-009173
EmbaseE-health StandingTall balance exercise for fall prevention in older people: Results of a two year randomised controlled trial.2021https://dx.doi.org/10.1136/bmj.n740
N.B. These documents automatically identified may not have been verified by the study sponsor.