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Trial registered on ANZCTR


Registration number
ACTRN12614000096651
Ethics application status
Approved
Date submitted
21/01/2014
Date registered
24/01/2014
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
iStoppFalls - Information and communication technologies (ICT) based system to predict and prevent falls
Scientific title
A randomised controlled trial of a home-based fall preventative exercise intervention program in older people using new technologies for continuous monitoring and prevention of fall risk
Secondary ID [1] 283946 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
iStoppFalls
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls
290971 0
Physical function 290973 0
Condition category
Condition code
Injuries and Accidents 291312 291312 0 0
Other injuries and accidents
Musculoskeletal 291313 291313 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291314 291314 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of the project and its consortium partners is to evaluate innovative home-based technologies for continuous monitoring and prevention of falls in community-dwelling older adults. This approach will enable tailoring individualised prevention programs coached by iStoppFalls, including exercise and education. Various different home-based technologies are employed:
1. The PC/ Microsoft Kinect 'Registered Trademark' based fall preventive exercise game (exergame ) facilitates real preventive exercise training, where data is acquired by unobtrusive sensing by PC/ Microsoft Kinect 'Registered Trademark'.
2. The Knowledge Based System (KBS) enables secure data management.
3. The iTV application utilized the Microsoft Kinect 'Registered Trademark' device. It provides all the relevant KBS data (personal health advisor), and thus provides the necessary information to include fall-related education and other exercise-related components.
4. The Philips Senior Mobility Monitor (SMM) unobtrusively and regularly monitors mobility in daily life.
The 16-week exercise intervention primarily targets balance and strength properties and is suited to the functional level and interests of older people. The content of the iStoppFalls fall prevention exercise program was based on evidence-based fall prevention interventions targeting muscle strength and functional balance and mobility in older adults. The exercises selected for the prevention program were adapted to be incorporated into a videogame setting. The strength exercises were adapted into a videogame-based training program and the balance exercises into balance games. To maintain the challenge of the games to maximise improvements in ability and skill level, the level of difficulty is gradually increased within each game.

Sixty community-dwelling older people will be advised to complete a minimum of 3 sessions per week (30 to 60 minutes/session), adding up to at least 120 minutes of system use per week. The intervention will be unsupervised and participants will exercise in their own homes. Instructions will be provided at the beginning of the study period when the system is installed. To encourage adherence, participants will be contacted by phone after weeks 1, 4, 8, 12 or if data upload shows non-adherence in between (non-use of the system for 5 days). In addition participants will be provided with a phone number to call if they have questions or problems related to system.
Intervention code [1] 288638 0
Prevention
Comparator / control treatment
The control group will receive no intervention, but an information brochure about common fall risk factors.
Participants in the control group will be provided with and education booklet about different fall risk factors (i.e., vision impairment, medication use, foot pain, vitamin D insufficiency) at the beginning of the trial and asked to maintain their usual activities. Participants will be provided with a phone number which they can call if they have questions or problems related to content of the educational material.
Control group
Active

Outcomes
Primary outcome [1] 291305 0
Physiological function and fall risk score using the Physiological Profile Assessment (PPA).
Timepoint [1] 291305 0
At baseline and at the end of the 4-month intervention period.
Primary outcome [2] 291306 0
Balance, strength and mobility measures assessed via iStoppFalls Kinect 'Registered Trademark' system and SMM.
Timepoint [2] 291306 0
At baseline and at the end of the 4-month intervention period.
Primary outcome [3] 291307 0
Quality of life by the European Quality of Life-5 Dimensions (EQ-5D-5L).
Timepoint [3] 291307 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [1] 306477 0
Detailed information about falls and their circumstances.
Timepoint [1] 306477 0
At baseline and at the end of the 4-month intervention period. Additionally, the participants will fill out monthly falls calendars.
Secondary outcome [2] 306478 0
Changes in cognitive performance assessed by the neuropsychological tests (i.e., Addenbrook’s Cognitive Examination, Trail Making Test, Victoria Stroop Test).
Timepoint [2] 306478 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [3] 306479 0
Physical performance measures (i.e., Timed Up & Go, Short Physical Performance Battery, 10 m walking, hand grip)
Timepoint [3] 306479 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [4] 306480 0
Frequency and duration of planned and more casual day-to day activity as assessed by the Incidental and Planned Exercise Questionnaire (IPEQ).
Timepoint [4] 306480 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [5] 306481 0
Attitude towards physical activity with the 18-item Physical Activity Enjoyment Scale (PACES).
Timepoint [5] 306481 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [6] 306482 0
Fear of falling assessed using the 30-item Shortened Iconographical-Falls Efficacy Scale (Icon-FES).
Timepoint [6] 306482 0
At baseline and at the end of the 4-month intervention period.
Secondary outcome [7] 306483 0
Compliance/adherence to the exercise intervention.
Timepoint [7] 306483 0
Throughout the intervention period with exercise diaries.

Eligibility
Key inclusion criteria
Living in the community; aged 65 years and over; ambulant (stand unaided and go without a walking aid for 20 m, walking aid for activities of daily living is accepted); having a flat screen TV (LCD, LED or Plasma) with HDMI port; internet connection; able to watch TV with their glasses from 3 m away; having enough space for system use.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Resided in a high-care residential facility (hospital, nursing/residential home, assisted living); insufficient (English) language skills to understand the assessment and/or intervention procedures; cognitive impairment (Mini-Cog: 1-2 recalled words and abnormal CDT); any travelling during the intervention phase planned for more than 2 weeks; medical conditions that prevent participation in a regular exercise program (verified via medical clearance form by the participant’s general practitioner).

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 recruited at retirement villages through oral presentations, flyers, posters, and advertisements.
After a potential participant fulfills all eligibility criteria, concealed allocation will be performed via central randomization.
Investigators will be blinded to whether a participant is in the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer will be used. The central randomisation office is remote from participant recruitment sites. The person performing the randomisation will not be involved in any assessments of this study. Screening for eligibility and pre-assessment will be undertaken before randomisation.
Random allocation (allocation ratio 1:1) into one of the 2 groups (intervention/control) will be performed.
Couples (participants living in the same household) will be randomized into their own blocks.
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
between-group:

Differences at baseline will be explored using Chi square (discrete variables) and Student t-tests (continuous variables).
Between-group comparisons of continuous measures will be made using general linear models (ANCOVA) controlled for baseline performance and other confounding variables if required. Negative binomial regression will be used to test for differences in fall rates between groups.

An intention-to-treat approach will be used for all between-group analyses.

The estimated sample size of 52 participants is based on a large effect for the PPA as outcome measure (effect size f=0. 40, ANCOVA, Alpha 5%, Power 80%, Numerator df 1, Number of groups 2, Number of covariates 1). With an anticipated dropout of 15%, 60 participants will be recruited.

The Alpha level will be set to 5%.

within-group:

Paired t-tests and repeated measures ANOVA will be used to analyse changes within groups and to explore subgroups (e.g. different doses) in the intervention group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288585 0
Government body
Name [1] 288585 0
National Health and Medical Research Council
Address [1] 288585 0
GHD Building Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Country [1] 288585 0
Australia
Funding source category [2] 288586 0
Other
Name [2] 288586 0
The Seventh Framework Programme (FP7) Aging and Well-being Grant
Address [2] 288586 0
European Commission
B-1049 Brussels
Belgium
Country [2] 288586 0
Belgium
Primary sponsor type
Individual
Name
Dr Kim Delbaere
Address
Falls and Balance Research Group
Neuroscience Research Australia
Barker St
Randwick 2031 NSW
Country
Australia
Secondary sponsor category [1] 287294 0
Individual
Name [1] 287294 0
Professor Stephen Lord
Address [1] 287294 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker St
Randwick 2031 NSW
Country [1] 287294 0
Australia
Other collaborator category [1] 277774 0
University
Name [1] 277774 0
University Siegen
Address [1] 277774 0
University Siegen
3 Herrengarten
Siegen, 57072
Germany
Country [1] 277774 0
Germany
Other collaborator category [2] 277775 0
University
Name [2] 277775 0
Deutsche Sporthochschule Koln (German sport university, Cologne)

Address [2] 277775 0
Deutsche Sporthochschule Koln (German sport university, Cologne)
6 Am Sportpark Muengersdorf
Koln, 50933
Germany
Country [2] 277775 0
Germany
Other collaborator category [3] 277776 0
University
Name [3] 277776 0
Austrian Institute of Technology GmbH
Address [3] 277776 0
Austrian Institute of Technology GmbH
1 Donau-City-Strasse
Wien, 1220
Austria
Country [3] 277776 0
Austria
Other collaborator category [4] 277777 0
University
Name [4] 277777 0
Instituto De Biomecanica De Valencia

Address [4] 277777 0
Instituto De Biomecanica De Valencia
Universidad Politecnica De Valencia Edifico 9C Camino De Vera
Valencia, 46022
Spain

Country [4] 277777 0
Spain
Other collaborator category [5] 277778 0
Commercial sector/Industry
Name [5] 277778 0
Philips Electronics Nederland B.V. (PRE)(Philips Research)
Address [5] 277778 0
Philips Electronics Nederland B.V. (PRE)(Philips Research)
525 Boschdijk
Eindhoven, 5621JG
Netherlands
Country [5] 277778 0
Netherlands
Other collaborator category [6] 277779 0
Commercial sector/Industry
Name [6] 277779 0
KAASA Solution GMBH
Address [6] 277779 0
KAASA Solution GMBH
13 Zollhof
Dusseldorf, 40221
Germany
Country [6] 277779 0
Germany
Other collaborator category [7] 277780 0
University
Name [7] 277780 0
University of New South Wales
Address [7] 277780 0
University of New South Wales
High Street, Kensignton,
Sydney, 2052
Australia
Country [7] 277780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290449 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 290449 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 290449 0
Australia
Date submitted for ethics approval [1] 290449 0
Approval date [1] 290449 0
19/12/2013
Ethics approval number [1] 290449 0
HC12316

Summary
Brief summary
This project addresses the urgent health care problem of falls in old age that affects a rapidly increasing number of people in Australia and is geared towards self-management of fall-related risk factors in old age. Technology-based solutions have potential to increase accuracy of fall prediction tools and develop standardized tailored intervention strategies. The emphasis of the project is not on laboratory research, but on active implementation of existing technologies and evidence-based fall prevention strategies for older people living in the community. The primary aim of the project is to develop and evaluate innovative home-based technologies for continuous monitoring and prevention of falls risk in older people.
Trial website
http://www.istoppfalls.eu/
Trial related presentations / publications
see http://www.istoppfalls.eu/
Public notes

Contacts
Principal investigator
Name 45738 0
Dr Kim Delbaere
Address 45738 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker St
Randwick 2031 NSW
Australia
Country 45738 0
Australia
Phone 45738 0
+61 2 9399 1066
Fax 45738 0
Email 45738 0
k.delbaere@neura.edu.au
Contact person for public queries
Name 45739 0
Dr Kim Delbaere
Address 45739 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker St
Randwick 2031 NSW
Australia
Country 45739 0
Australia
Phone 45739 0
+61 2 9399 1066
Fax 45739 0
Email 45739 0
k.delbaere@neura.edu.au
Contact person for scientific queries
Name 45740 0
Dr Kim Delbaere
Address 45740 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker St
Randwick 2031 NSW
Australia
Country 45740 0
Australia
Phone 45740 0
+61 2 9399 1066
Fax 45740 0
Email 45740 0
k.delbaere@neura.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary