The SafeTrip Study - Step Training to Reduce Falls in Older Adults
- Conditions
- Fall InjuryFall
- Interventions
- Device: Reactive Balance TrainingOther: Control
- Registration Number
- NCT04602858
- Lead Sponsor
- Neuroscience Research Australia
- Brief Summary
Falls in older people are devastating, widespread, costly and increasing in the aging Australian population. Although falls occur in approximately one third of older adults, certain population groups such as the sarcopenic/frail present with further elevated risk of falls. Many exercise interventions have been trialled but systematic review evidence indicates such programs reduce fall rates by an average of only 20% and encounter issues such as compliance.
Reactive balance training (also called perturbation-based balance training) utilises a task-specific approach to balance training, applying repeated exposure to unpredictable perturbations that mimic balance disturbances experienced in daily life. Evidence suggests 50% reductions in falls might be achievable in a time efficient manner with reactive balance training but more evidence is required.
In this study, ecologically valid, unpredictable trips and slips will be exposed to older people in a safe environment to train their reactive balance. Three 40 min weekly training sessions will be followed by 3-monthly retraining session over one year (40 min x 6 training sessions = 4 hours of training in total). The neuromuscular, physiological, psychological, behavioural effects of the reactive balance training will be comprehensively examined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Older persons - aged 65 years and older
- Community-dwelling
- Ability to walk 500m without rest or use of mobility aids
- Diagnosed neurological disease - eg Parkinson's disease, multiple sclerosis
- Cognitive impairment and dementia
- Bone fractures or joint replacement (in the past year)
- Pre-existing medical conditions from which the medical practitioner has advised not to exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reactive Balance Training Reactive Balance Training Participants randomised to the intervention group will initially undertake 3 x 40 min training sessions of reactive balance training over 3 weeks followed by 3-monthly retraining sessions at 3, 6 and 9 months, and final assessment at month 12. During the training, participants will be exposed to unpredictable slips and trips whilst they are walking on the Trip and Slip Walkway (Okubo et al. 2019). They will be required to consistently walk at their normal walking pace using our gait regulation protocol (i.e. individually adjusted stepping tiles and metronome). Each training session will involve up to 30 trips and slips which progress in unpredictability. Participants will also receive a "Staying active and on your feet" fall prevention booklet containing guidance regarding fall risk factors including exercise, diet, vision, footwear, medications and home safety. Control Control After exposing the control group to one trip and one slip at baseline, participants will then be provided with the "Staying active and on your feet" fall prevention booklet, an educational booklet providing guidance on fall risk factors including exercise, diet, vision, footwear, medications and home safety. The control group will then return for a reassessment after 12 months.
- Primary Outcome Measures
Name Time Method Laboratory induced falls 12 month re-assessment Fall incidence after slips and trips in the laboratory (Okubo et al., 2019). A fall will be defined by the harness supported load when it exceeded 30% of the person's body weight (Yang et al., 2011).
Slips in daily life Throughout a follow-up period (one year from randomisation) Number of slips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Trips in daily life Throughout a follow-up period (one year from randomisation) Number of trips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
- Secondary Outcome Measures
Name Time Method Margin of stability 12 month re-assessment Margin of stability (Hof et al., 2005) during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Fear of falling 12 month re-assessment Fear of falling will be assessed using the Falls Efficacy Scale - International (Yardley et al., 2005), a 16 item scale scored out of 64 where higher scores indicate greater fear of falling
Fall Behavioural Scale 12 month re-assessment Fall risk awareness and behaviours will be assessed using the 24-item Fall Behavioural Scale (Clemson et al., 2008). Mean scores range from 1.0 to 4.0 in which higher scores indicate safer behaviours
Catch-inhibition accuracy 12 month re-assessment Catch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).
Falls in daily life Throughout a follow-up period (one year from randomisation) Number of falls in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Anxiety 12 month re-assessment Anxiety will be assessed using the General Anxiety Disorder - 7-item scale (Spitzer, 2006), a 21 point scale where higher scores indicate greater anxiety
Muscle activation amplitude (semitendinosus) 12 month re-assessment Muscle activation amplitude will be recorded using surface electromyography on the semitendinosus. This will be assessed as percentage of the activation level during the trip and slip trials relative to the maximal voluntary contraction.
Fall Risk 12 month re-assessment A summary fall risk score will be calculated from the Physiological Profile Assessment short form which includes tests of vision, balance, proprioception, reaction time and strength (Lord et al., 2003).
Volitional Stepping Reaction time 12 month re-assessment Volitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).
Stepping inhibition 12 month re-assessment Stepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.
Executive function 12 month re-assessment Executive function will be assessed using the Trail Making Test A and B (Tombaugh et al., 2004). Test scores B - A will be used as a measure of executive function.
Extrapolated centre of mass 12 month re-assessment Extrapolated centre of mass (Hof et al., 2005) during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Fall risk awareness and behaviours Month 6 (middle of the follow-up period) Fall risk awareness and behaviours will be assessed using the 24-item Fall Behavioural Scale (Clemson et al., 2008). Mean scores range from 1.0 to 4.0 in which higher scores indicate safer behaviours
Muscle activation onset latency (semitendinosus) 12 month re-assessment Time (milliseconds) from a trip/slip onset to muscle activation onset will be recorded using surface electromyography on the semitendinosus. Muscle activation onset will be defined when the activation level exceeds 3 standard deviation above the baseline level.
Physical activity levels 12 month re-assessment Physical activity levels will be assessed using the Incidental and Planned Exercise Questionnaire (Delbaere et al., 2009). A total physical activity (hours per week) in the past 3 months will be estimated.
Range of trunk sway 12 month re-assessment Range of trunk sway during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Muscle activation amplitude (rectus femoris) 12 month re-assessment Muscle activation amplitude will be recorded using surface electromyography on the rectus femoris. This will be assessed as percentage of the activation level during the trip and slip trials relative to the maximal voluntary contraction.
Step length 12 month re-assessment Step length during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Muscle activation onset latency (rectus femoris) 12 month re-assessment Time (milliseconds) from a trip/slip onset to muscle activation onset will be recorded using surface electromyography on the rectus femoris. Muscle activation onset will be defined when the activation level exceeds 3 standard deviation above the baseline level.
Adverse events during reactive balance training Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9 Adverse events such as muscle soreness, discomfort, pain or injury will be collected by staff during reactive balance training sessions.
Enjoyment of reactive balance training Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9 Enjoyment of reactive balance training will be assessed using the 8-item Physical Activity Enjoyment Scale (PACES-8, Mullen et al., 2011). Scores range from 8 to 56 with higher scores indicate greater enjoyment.
Trial Locations
- Locations (1)
Neuroscience Research Australia
🇦🇺Randwick, New South Wales, Australia