Current clinical trials in Australia and New Zealand evaluating falls/fall injury outcomes

Study Title
(Click to go to the clinical trial registration)
SummaryChief Investigator
Preventing hospital falls: a qualitative analysis of the views of patients and clinicians on how to minimise riskFalls are a debilitating and common problem in Australian hospitals and it is estimated that between 310 falls occur per 1,000 bed days in Australian hospitals. Even though they are associated with increased length of stay and injuries, falls mitigation strategies have not had a great deal of success to date in hospital environments. Previous attempts to prevent falls have focused on clinician education and environmental modifications. The current project will use qualitative methods for a series of interviews with patients and clinicians to understand their views and knowledge on falls prevention educational interventions.Prof Meg Morris, La Trobe University
Does four weeks of motor imagery training improve physical and perceived ability of mobility and balance in older adults?It is well established that with normal ageing come reductions in mobility, physical ability and associated functional performance. It has been identified that a mismatch between actual physical abilities and perceived physical ability are associated with increased falls risk and risk-taking behavior in older adults. This mismatch between physical and perceived abilities may be partly due to impairments in motor planning which commonly deteriorates with ageing. A simple way to measure the association between actual and perceived abilities is to compare the difference (error) in time or distance between actual and imagined (or perceived) performance.
Motor imagery is the imagining of an action without its physical execution and can effectively improve motor skill and promote motor leaning as it activates areas of the brain that are normally activated during actual physical performance. Motor imagery has been shown to improve muscle strength and mobility, but it is not known whether motor imagery can influence the relationship between actual and perceived ability.
The aim of this study is to identify whether four weeks of motor imagery training can improve physical abilities together with perception of motor abilities in older adults.
Dr Vaughan Nicholson, Australian Catholic University
A tailored falls prevention program for people aged 50+ with mental illness living in the community: A pilot randomised controlled trial.The purpose of this study is to evaluate if a tailored fall prevention program can reduce falls, reduce the risk factors for falls and improve balance, strength, confidence and the home environment for older people with a mental illness living in the community. The intervention in this study will be adapted from the Stepping On fall prevention program, which has been shown to reduce falls in typical older people living in the community. By adapting this program to the needs of older people with a mental illness, we hypothesise that these adaptations will results in improved falls and other fall-related outcomes.Dr Meryl Lovarini, The University of Sydney
Can hip protector devices prevent in-hospital fall-related injuries in frail older persons? The Hip-Frail StudyFrail older persons are at high risk of hospitalization due to acute events associated with chronic diseases. The combination of frailty, functional deterioration, and acute conditions substantially increase the risk of falling, and hence the likelihood of incurring a fall-related injury. Those injuries (i.e. fractures, soft tissue trauma, residual pain, etc.) not only have devastating consequences on an individual's quality of life but may also affect a hospital's reputation in the community. In addition, hospitals may face litigation claims and increased costs for patients who fall and suffer a major injury as a consequence. External hip protectors are comparable to padded undergarments and shield the trochanter, reducing the detrimental effects and force impacting the bone during a fall. Screening for patients at high risk of falling and providing high-risk patients with hip protectors as a preventive measure to avoid hip fractures and other fall-related injuries, not only improves public health, but can also save hospitals care and litigation costs. It has also been demonstrated to be a cost-effective intervention. However, the acceptance of hip protectors by frail older persons and those factors affecting in-hospital adherence remain unknown. This study will aim to assess the tolerability and acceptability of hip protectors and the prevention of fall-related injuries in hospitalised frail older persons.Prof Gustavo Duque, The University of Melbourne
Implementation of StandingTall: Determining eHealth fall prevention uptake and adherence in older people living in the communityStandingTall targets a major need for older people for whom falls are a real risk that can have debilitating impacts on quality of life. This project aims to evaluate the implementation of StandingTall in clinical practice and the community in multiple sites across Australia and Northern England. We will monitor exercise adherence, as well as acceptability and uptake of StandingTall in older people and health care workers. Our primary aim is to estimate mean adherence at each site with a confidence interval width of +/- 10 minutes. This project addresses the final steps needed to disseminate this innovative technology for widespread use by older people across Australia, UK and internationally.A/Prof Kim Delbaere, Neuroscience Research Australia
Preventing falls in older age with yoga-based exercise: effectiveness, cost-effectiveness and implementation This study aims to compare the effect on falls and other measures of health and wellbeing of:
a) a group-based yoga exercise program over 12 months, and
b) a seated home-based yoga relaxation program over 12 months. Participants allocated to the group-based yoga exercise program will attend yoga classes at established yoga studios with experienced yoga teachers for one hour, twice weekly for 40 weeks. Participants allocated to the yoga relaxation program group will attend two one-hour workshops to learn a relaxation yoga program. We hypothesise that greater effects on the rate of falls will be evident from the group-based yoga exercise program compared to the yoga relaxation program.
A/Prof Anne Tiedemann, Institute for Musculoskeletal Health
Standing Tall with Our Mob Program (STOMP) pilot trial to improve mobility, balance, physical activity, cognitive function and psychological well-being with older people in an urban Aboriginal community.The Koori Active and Healthy Ageing Project aims to develop new, effective, culturally appropriate healthy ageing approaches in collaboration with older Aboriginal people and partner communities in regional and urban NSW. A balance-based exercise mobile application developed at NeuRA was the preferred option selected by partnering communities and has been redeveloped to provide a culturally appropriate interface, incorporating cognitive activities to boost the potential benefits for healthy brain ageing and maintaining functional independence. To evaluate the feasibility of this program, a pilot randomised control trial, developed in collaboration with Aboriginal health workers, will be conducted, with key outcomes including improvements in dual task walking speed, physical activity, balance and fall risk, cognitive function, and social and emotional well-being. By implementing a technological platform, this program has the potential to improve access to dementia prevention, enable low-cost individualised program tailoring and facilitate transferability across diverse community settings.Dr Kylie Radford, Neuroscience Research Australia
Home-based, tailored intervention to reduce falls after stroke trial.Stroke survivors fall often with fall rates of more than twice that of the general older population, placing an enormous economic burden on the national health system and society in general. The aim of Falls After Stroke Trial (FAST) is to test the effect of home-based, tailored intervention to reduce falls. A sample of community-dwelling stroke (n=370) survivors who have completed formal rehabilitation will be randomly assigned to an experimental group (habit-forming exercise and safety training), or a control group (usual care). The primary outcome measures will be falls recorded daily by the participants and monitored monthly by a researcher blinded to group allocation. Secondary outcomes will be community participation, balance, self-efficacy, mobility, physical activity, health-related quality of life healthcare utilisation and costs.Prof Lindy Clemson, The University of Sydney
A falls, balance and bone health clinic: analysis of patient characteristics and outcomesThis study is a two-part longitudinal, observational study. Part 1 of the study will be a cross-sectional analysis ofroutinely collected data from the Prince of Wales hospital falls, balance and bone health clinic (1st of February 2019 - 31st of July, 2021) to proivde a descriptive analysis of attendees. Part 2 of the study will involve a follow-up questionnaire completed via telephone by patients that consent to be involved in this element of the study six to nine months after their clinic appointment date to gain isight into the uptake of clinic recommendations.

It is hypothesised that patients that have a positive attitude and intention towards falls prevention recommended by health professionals will be more likely to participate in such recommendations. Also patients that participate in multi-component recommendations (e.g. Stepping On falls prevention program) will have greater improvements in outcomes (e.g. number of falls, fear of falling) compared to patients in single component recommendations (e.g. medication review).
Dr Lindsey Brett, Macquarie University
Dementia prevention and risk Management Program for Aboriginal Australians - DAMPAA ProjectThis study aims to produce an Aboriginal Health Practitioner coordinated risk factor management program to reduce cognitive decline and functional impairment in Aboriginal Australians aged 45 years and over. The Dementia prevention and risk management program for Aboriginal Australians (DAMPAA) program will include AHP coordination and care planning of a) an exercise program including falls prevention strategies; b) cardiovascular risk management.
This will be achieved through a 5 year research project in partnership with three ACCHS’s by: 1) Refining and piloting an intervention program (DAMPAA) that targets key dementia risk factors for Aboriginal people, and is based on existing best practice guidelines and cultural and service provider recommendations.
2) Completing a randomized controlled trial (RCT) comparing the DAMPAA program with usual care;
3) Evaluating the efficacy and cost-effectiveness of the DAMPAA.
Significance: Given the rapid ageing of the Aboriginal population, the impact that dementia has on Aboriginal communities, and the resulting financial cost to society, there is a pressing need to develop and translate programs capable of reducing dementia in Aboriginal Australians. This project will produce a prevention program designed to meet the needs of Aboriginal Australians at risk of dementia.
Dr Kate Smith, University of Western Australia
StandingTall-plus Balance Confidence: an online cognitive behavioural therapy program to address concerns about falling in older peopleThe aim of this study to assess the effectiveness of an online cognitive behavioural program (myCompass) versus a health education program for 6 weeks at reducing concerns about falling in community-dwelling older people. The primary outcome (concern about consequences of falling) and secondary outcomes (concerns about falls, balance confidence, activity avoidance, depression, anxiety, health literacy and physical activity) will be measured in the form of a randomised controlled trial.A/Prof Kim Delbaere, Neuroscience Research Australia
StandingTall-Plus: A 1-year randomised controlled trial of a novel multifactorial intervention for preventing falls in older peopleFalls in older people are often caused by a concomitant decline across three domains: mobility, cognition and affect; or in other words, across moving – thinking – feeling domains. The aim of this trial is to test a program that is individually tailored to physical, cognitive and affective aspects (as opposed to medical pathologies) by taking a multifactorial profile approach to fall prevention. The use of technology will ensure that is easily accessible to do in the home and engaging to continue over a long period.

A randomised controlled trial will be conducted in 518 community-dwelling older adults at high-risk of falls. All participants will be assessed using a comprehensive test battery of known falls risk factors across physical, cognitive and affective domains. This will then be used to offer each participant a fully tailored program that is suited to their abilities and circumstances. Our primary aim is to reduce the number of falls over a 12-month follow-up period when compared to a health promotion program.

We hypothesise that our program will improve balance, cognitive function and mood, increase physical activity levels and reduce falls in older people, when compared to a health promotion program. This trial addresses a key gap in the understanding of falls interventions and application of personalized medicine and will provide direct evidence about the cost and effectiveness of a tailored multifaceted “best-bet” solution.
A/Prof Kim Delbaere, Neuroscience Research Australia
The Ironbark Study: Healthy Ageing for older Aboriginal peopleThe Ironbark Study is evaluating the effectiveness of a fall prevention program for older Aboriginal people (45 years and older), compared to a weekly elders group. Both arms of the trial involve an ongoing program delivered weekly by a local person, in a community setting. The Ironbark – Standing Strong program is a weekly exercise and discussion program aimed at preventing falls, and the Ironbark – Healthy Community program is a weekly program that involves discussions and social activities. The study design is a cluster randomised control trial and the 60 participating services across NSW, SA and WA are randomly assigned to either program. Services are required to recruit 10 - 15 eligible Aboriginal people, have strong connections with their local Aboriginal community, and have culturally appropriate venue and staff to deliver the program. Services will be supported through training and resources to implement either program. At the end of the trial, the control groups will have the opportunity to deliver the intervention program for a 6 month period, including all resources and equipment needed. It is anticipated that this trial will inform national policy and program delivery around falls prevention and healthy ageing among older Aboriginal people.Prof Rebecca Ivers, University of New South Wales
Preventing hospital falls by optimal screening: Educating health professionalsThis project evaluates an intervention designed to educate health professionals on how to use a new falls screening tool in hospitals. The eventual plan is to replace a historical Falls Risk Assessment Form (FRAT) (Form A) with a new, evidence-based screening form (Form B). This project will educate health professionals in the use of the new screening form, and will evaluate their views of its feasibility. This study also examines the views and experiences of health professionals on hospital falls risk screening and FRATs more generally.Prof Meg Morris, La Trobe University
Taurite Tu- Development of a strength and balance exercise programme that is engaging and relevant for Maori living in the Dunedin area, that positively affects the impact of falls for Maori.Te Runanga o Otakou has identified there is a gap in Fall Prevention services for Maori living in Te Runanga o Otakou takiwa. Evidence demonstrates that Maori do not recover as well from fall related injuries and have higher mortality rates following serious falls compared to non-Maori. Taurite Tu research is in response to this health issue.
Research objectives include: a) creating a relevant and engaging balance and strengthening exercise programme responsive to needs of Maori b) identifying and reducing falls risks for Maori, and c) increasing hauora research capacity within Te Runanga o Otakou.
Kaupapa Maori Research and Participatory Action Research methodologies will apply to this project. Potential health outcomes for Maori living in Te Runanga o Otakou takiwa include increased participation of in balance and strengthening exercise programmes, and decreased falls risk and related costs. An associated outcome is increased hauora research capacity within Te Runanga o Otakou.
Ms Katrina Anne Potiki Bryant, University of Otago
Staying UpRight in Residential Care: An exercise program for older people living in residential care designed to reduce rates of fallsOlder people fall frequently in residential aged care with disastrous consequences including injury and hospitalisation. Preventing falls in care homes has been difficult. This project tests an exercise programme specifically designed for aged care residents, including those with dementia in comparison to seated exercises, to see if falls and injury from falls can be prevented. A novel feature of this study is body-worn sensor monitoring of participants to establish gait parameters and activity patterns. Amount of activity will be used as an outcome for the trial, falls/active time, and gait patterns and parameters will be examined between those with and without dementia and in response to the programme.. Cost-effectiveness analyses will see whether there is a return on investment. If this exercise programme is successful, those in care homes will benefit and costs will be saved.Prof Ngaire Kerse, The University of Auckland
SAFE-PD - Stepping to Avoid Fall Events in Parkinson's diseaseOur recent systematic review showed that both volitional and reactive step training reduce falls by approximately 50% in healthy older adults. Our recently completed randomized control trial (RCT) confirmed safety and effectiveness of home-based volitional step training in people with Parkinson's disease (PD). We hypothesise that a combination of volitional and reactive step training will provide additional benefits, underpinned by differential motor control mechanisms of action. This is a single blind RCT using a parallel arm design including a 12-week intervention, pre- and post-intervention assessments and 6-month follow-up for falls. Our RCT will be the first to clarify the effectiveness of combined volitional and reactive step training on risk of falling in people with PD using state-of-art technology.Prof Stephen Lord, Neuroscience Research Australia
Training protective stepping responses to trips and slips in people with multiple sclerosisThis project will examine feasibility, mechanisms and efficacy of reactive step training as a fall-prevention strategy for people with MS. Forty-four people with MS will be recruited and assessed for balance recovery responses after slips and trips. Equipped with a full-body safety harness and foot protectors, People with MS will be exposed to a slip (70cm length) and a trip (14cm height) using our perturbation system. Twenty-two participants randomized to the intervention group will undertake 2 weekly individual 50-minute sessions (100 minutes in total) with each session focusing on balance recovery from a mix of trips and slips (week 2). Intensity of the training (e.g. gait speed, slip distance/speed and trip height) will be individualized and progressed according to participant ability. The control group will undertake 2 weekly 50-min session of sham training. Following training/sham, balance recovery response to slips and trips will be assessed. Kinematic, kinetic and physiological data will be collected to explore mechanisms for how people with MS improve their balance recovery responses.Prof Stephen Lord, Neuroscience Research Australia
Reactive step training to improve reactive responses to slips and trips in older adults: a randomized controlled trial`Falls among older adults cause serious challenges for the individual and health care systems, including bone fractures. Our recent systematic review and meta-analysis has shown that reactive step training (repeated exposure to balance perturbations) can reduce falls by approximately 50% (Okubo et al., 2016). However, the methods to generate perturbations (e.g. slips) in previous studies have been considerably heterogeneous and have limitations to training reactive balance control. We have developed a novel overground perturbation system which can generate both slips and trips in random locations. Since this system can provide unpredictable slips and trips, it is theoretically possible to train specifically reactive balance control (as opposed to proactive balance control or prediction). This randomized controlled trial will examine the effectiveness of the reactive step training using this perturbation system in older adults.Prof Stephen Lord, Neuroscience Research Australia
StandingTall-plus Balance Confidence: an online cognitive behavioural therapy program to address concerns about falling in older peopleThe aim of this study to assess the effectiveness of an online cognitive behavioural program (myCompass) versus a health education program for 6 weeks at reducing concerns about falling in community-dwelling older people. The primary outcome (concern about consequences of falling) and secondary outcomes (concerns about falls, balance confidence, activity avoidance, depression, anxiety, health literacy and physical activity) will be measured in the form of a randomised controlled trial.A/Prof Kim Delbaere, Neuroscience Research Australia
The Exercise for the Prevention of Falls in Older Adults with Sarcopenic Obesity Pilot Study (ESPRESSO-P)."Sarcopenia" describes the age-related decline in skeletal muscle mass and function which contributes to increased risk of disability and loss of independence. In the presence of obesity, these effects may be exacerbated, and we have demonstrated that the "sarcopenic obese" population have increased risk for falls and fractures. We hypothesise that targeted exercise can significantly improve muscle strength, balance and bone health in sarcopenic obese older adults. We will test this hypothesis by conducting a pilot randomised controlled trial (RCT) of a multi-component exercise intervention in 56 obese older adults with poor physical performance. The findings from this pilot RCT will contribute to the development of guidelines for exercise in obese older adults at increased risk for falls and fractures.Dr David Scott, Monash Medical Centre
The effects of health coaching with accelerometer feedback on physical inactivity in older people at risk of fallsOne in three older people fall at least once a year and sedentary behaviour (more than 10 hours of inactivity during waking hours) is a risk factor. These dual problems need to be addressed effectively as the ageing population increases. This study is a prospective single-blinded randomized controlled trial (RCT) with a follow-up period of 6 months. This trial aims to establish the feasibility of an individualised goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people with a recent fall or at risk of one compared to a health advice brochure over 24 weeks. Forty community-dwelling older adults will be randomised to the intervention group and control group respectively. Primary outcomes include feasibility of the intervention and change in sedentary time measured at 12 and 24 weeks after randomisation. Secondary outcomes include falls, fear of falling and walking speed. This trial will address a key gap to evaluate an intervention that could be implemented within the primary health care settings.Dr Kareeann Khow, Adelaide G-TRAC Centre
Investigating a novel technological solution to prevent falls in older people in hospitalBackground: Although current best practice recommendations contribute to falls prevention in hospital, falls and injury rates remain high. There is a need to explore new interventions to reduce falls rates, especially in geriatric and general medical wards where older patients and those with cognitive impairment are managed.
Design and Methods: A 3-cluster stepped wedge pragmatic trial of the Ambient Intelligent Geriatric Management (AmbIGeM) (wearable sensor device to alert staff of patients undertaking at-risk activities) system for preventing falls in older patients compared to standard care. The trial will be conducted on three acute/subacute wards in two hospitals in Adelaide and Perth, Australia.
Participants: Patients aged >65 years admitted to study wards. A waiver and opt-out of consent was obtained for this study. Patients requiring palliative care will be excluded.
Outcomes: The primary outcome is falls rate; secondary outcome measures are: i) proportion of participants falling, ii) rate of injurious in-patient falls/1000 participant bed-days, iii) acceptability and safety of the interventions from patients and clinical staff perspectives, and iv) hospital costs, mortality and use of residential care to 3 months post-discharge from study wards.
Discussion: This study investigates a novel technological approach to preventing falls in hospitalised older people. We hypothesize that the AmbIGeM intervention will reduce falls and injury rates in participating wards, with an economic benefit attributable to the intervention. If successful, the AmbIGeM system will be a useful addition to falls prevention in hospital wards with high proportions of older people and people with cognitive impairment.
Prof Renuka Visvanathan, University of Adelaide
Physical activity education in community rehabilitationClients attend Alfred Health Community Rehabilitation Program for goal-oriented rehabilitation following a change in their health status (i.e. stroke, joint replacement, falls). Many of these clients are elderly and/or suffer from one or more chronic health conditions (i.e. osteoarthritis, diabetes, heart disease).
Rehabilitation is targeted to address current goals and concerns, however no formal education is given about the benefit of adherence to a long-term physical activity program.
This study will assess the feasibility of delivering a single session intervention of physical activity education and counselling, geared towards encouraging long-term physical activity. The intervention will be delivered at the end of the client’s community rehabilitation program encounter.
Dr Anne Holland, The Alfred Centre
A Safe Transfer Program to Improve Gait and Reduce Falls in Cognitively Impaired Older Adults with Higher Level Gait Disorders: A Pilot StudyThis research project will investigate the feasibility and acceptability of combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques in a safe transfer program to improve gait and prevent falls in adults aged 65 and over with mild to moderate cognitive impairment and higher level gait disorders. The assessments and intervention will be conducted at participants' home by a senior occupational therapist who is a co-investigator of the study. The 3 week intervention program starts with more intensive therapy in week 1 (4 sessions, 30min each session) and gradually decreases the intensity in week 2 (2 sessions, 30min each session) and week 3 (1 session, 30min each session). Following demonstration of the transferring task by the therapist, participants are provided with verbal cues prior to each step when performing the task (EL) and the time intervals between each session gradually increase (SR). The transfer training practice will be generalised into real life activities in week 2 and week 3 of the program. Follow up assessments at 3 months post intervention will also be conducted at the participants home. This project will form the pilot study for a larger multi-centre clinical trial, which will assess the long-term effect of this novel falls prevention program targeting older adults with cognitive impairment and higher level gait disorders.A/Prof Lee-Fay Low, University of Sydney
The effect of cognitive and cognitive-motor training on falls in older peopleNo studies have examined the potential for cognitive or cognitive-motor training to prevent falls in older people, despite good evidence of fall-related cognitive and physical improvements following both intervention types. We have developed and validated a home-based computerised training intervention that can be delivered identically, either while seated (cognitive) or while standing and undertaking balance exercises (cognitive+motor). This unique design will allow us to assess whether cognitive and cognitive+motor training can prevent falls, as well as the neural, physiological, physical and neuropsychological mechanisms behind the intervention effects. We will conduct a randomised controlled trial of 750 older people, to determine the effects of cognitive and cognitive+motor training, compared with a no-intervention control group, in preventing falls and related physical, cognitive and neurological measures in older people. We hypothesise both interventions will significantly prevent falls and fall-related measures of physical and cognitive functions. Any differential effects of the interventions will provide valuable insights into the intervention components required for efficacious fall prevention, and those required for neural, neuropsychological and physical benefits.Dr Daina Sturnieks, Neuroscience Research Australia
An interactive step training system to reduce falls in people with multiple sclerosis: a randomised controlled trialFalls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls.
Increased fall risk and fear of falls have been shown to significantly affect quality of life
and curtail activities among people with MS. Therefore, effective interventions to reduce
fall risk in PwMS are urgently needed.

Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in
MS reveal important balance, coordination and cognitive determinants of falls. Based on
these results, we propose a randomised single-blind controlled trial (RCT) to
evaluate a step training intervention designed to prevent falls in PwMS. The proposed
trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required.

It is expected that if the research confirms effectiveness of treatment strategies,
implementation of clinical interventions will contribute to reduced fall rates in PwMS and
associated injury-associated costs, reduced fear of falls and improved quality of life for
PwMS.
Prof Stephen Lord, Neuroscience Research Australia