None listed
Conditions
Brief summary
Falls 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.
Interventions
The intervention comprises 1 year (52 weeks) of tailored balance exercise, cognitive behavioural therapy and cognitive motor training (CMT). The intervention group will receive up to 3 programs, as described below. This trial will continue via telehealth from March 2020 onwards. 1. All intervention participants will receive the StandingTall-Balance exercise program on a tablet computer from week 1 up to and including week 52. The home-based exercise training offers an effective way for people to improve their balance, reduce their fall risk and increase their physical activity with greater confidence. It comprises standing balance (e.g. standing on a foam surface), transferring (e.g. sit-stand transitions), walking (e.g. walking in circles or to targets in a grid), stepping (e.g. step and lift) and box (e.g. step up and over a box) exercises. The program is fully optimised to deliver unsupervised and individually-tailored balance exercises that increase in difficulty over time through mobile technology (tablet and internet). Participants will be instructed to complete 40 min/wk in the first 2 weeks, and increase the exercise dose by 20 min fortnightly, to finally reach a dose of 2 or 3 hr/wk based on their fall risk score on the Physiological Profile Assessment (2 hours if PPA < 0.6; 3 hours if PPA >= 0.6 unless concurrent StandingTall-CMT is prescribed) or based on their ability to stand with both feet in tandem (2 hours if >= 30 seconds; 3 hours if < 30 seconds) if recruited after March 2020. Participants have full autonomy to choose the timing and duration of their sessions. 2. Intervention participants with depressive symptoms (GDS-15 >= 5) will receive a fully-automated cognitive behavioural therapy program (myCompass) delivered through a tablet or computer in people’s homes with no therapist input from week 1 up to and including week 7. The myCompass program offers evidence-based and interactive psychological modules that users can complete via the internet on a tablet or computer in their homes. Each module comprises three 10-minute sessions and includes activities for users to complete on the computer. There are home practice tasks recommended for participants to complete between the online sessions (i.e. completion of one full module per week followed by 1 week of practice), which are intended to promote skill generalisation. Participants will be instructed to complete 1 module per week and self-monitor daily (30 min/wk), with the aim of completing 3 full modules during the first 7 weeks of the trial. 3. Intervention participants with poor executive functioning (TMT B-A >=50s) will receive the StandingTall-Cognitive Motor Training program to improve executive function and attention on a tablet computer from week 5 up to and including week 52. Concomitant cognitive tasks, relying primarily on executive function, are added to StandingTall-Balance exercises by using auditory and visual cues. Three core executive functions are engaged: inhibition (the ability to consciously override automated or dominant responses), working memory (the ability to hold, process, and manipulate information in mind) and task shifting (the ability to switch flexibly between tasks or mental sets). Participants will receive 50% (if on a 2 hr StandingTall dose) or 33% (if on a 3 hr StandingTall dose) of their weekly StandingTall-Balance exercise dose, with a final dose of 1 hr/wk, as StandingTall-Cognitive Motor Training. All programs are delivered in a similar way through a tablet computer, and use of personalised encouragement messages and compliance-promoting features. * Tailoring of total exercise recommendation will be guided by a multifactorial fall risk assessment (PPA/standing balance, GDS, TMT) and will remain tailored to the participant’s abilities through the intervention over the duration of the trial (1 year). * Recruited before March 2020: Following the baseline assessment at Neuroscience Research Australia, an exercise physiologist from the research team will explain to the participant how to use the StandingTall and myCompass programs during a home visit with an approximate duration of 2 hr. * Recruited after March 2020: Following a baseline assessment via encrypted teleconferencing software, an exercise physiologist from the research team will explain to the participant how to use the StandingTall and myCompass programs during a separate onboarding teleconference call with an approximate duration of 2 hr. * All participants will receive a phone call around week 4 to remind people of the health promotion education program and, when relevant, follow up on adherence and inform intervention participants with poor executive functioning that the StandingTall-Cognitive Motor Training program will become available as of week 5. * Participants will be given their own login and password to access the StandingTall and myCompass programs on a tablet computer. Tablets will be provided for participants without home computers or internet access. * Participant adherence (training duration and frequency) will be monitored following automatic data transfer to a server and examined weekly. Participants not engaging in the minimum weekly training duration for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence for the first 6 months. * Phone, email support and home visits will be available as needed for the entire duration of the study.
Sponsors
Study design
Eligibility
Inclusion criteria
Healthy volunteers at high-risk of falls based on the following criteria: experienced 1+ falls in the past 6 months AND/OR have a self-reported fear of falling AND/OR are 80+ years. * 65 years of age or older * Living in the community * Proficient in English * 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 * If included from March 2020 onwards, participants will need to have a device with internet access which they can use to perform the telehealth baseline assessment.
Exclusion criteria
* Unstable or acute medical condition that precludes exercise participation * Progressive neurological condition (such as Parkinson’s disease, Multiple Sclerosis) * Cognitively impaired defined as a Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score <8 * Severe depression or suicidal thoughts (Patient Health Questionnaire-9 score >=20 or scoring 3 on the last question) or acute psychiatric condition with psychosis * Currently participating in a fall prevention program