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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04602858
Registration number
NCT04602858
Ethics application status
Date submitted
14/09/2020
Date registered
26/10/2020
Date last updated
21/03/2024
Titles & IDs
Public title
The SafeTrip Study - Step Training to Reduce Falls in Older Adults
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Scientific title
Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention
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Secondary ID [1]
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U1111-1258-0513
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Secondary ID [2]
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HC190952
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fall
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Fall Injury
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Reactive Balance Training
Other interventions - Control
Experimental: 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.
Active Comparator: 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.
Treatment: Devices: Reactive Balance Training
Reactive balance training involves the use of the Trip and Slip walkway that is able to expose participants to unpredictable trips and slips. Trips and slips will occur at random location on the walkway and times within the gait cycle, with the participants receiving 3-monthly retraining sessions along with an educational booklet.
Other interventions: Control
The control intervention will be receiving an educational booklet as part of standard care. The education component will target a variety of fall risk factors and provide strategies to mitigate these risk factors.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Laboratory induced falls
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Assessment method [1]
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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).
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Timepoint [1]
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12 month re-assessment
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Primary outcome [2]
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Trips in daily life
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Assessment method [2]
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Number of trips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
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Timepoint [2]
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Throughout a follow-up period (one year from randomisation)
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Primary outcome [3]
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Slips in daily life
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Assessment method [3]
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Number of slips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
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Timepoint [3]
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Throughout a follow-up period (one year from randomisation)
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Secondary outcome [1]
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Falls in daily life
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Assessment method [1]
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Number of falls in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
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Timepoint [1]
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Throughout a follow-up period (one year from randomisation)
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Secondary outcome [2]
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Fall Risk
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Assessment method [2]
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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).
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Timepoint [2]
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12 month re-assessment
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Secondary outcome [3]
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Fear of falling
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Assessment method [3]
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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
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Timepoint [3]
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Week 3 (following the third training session)
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Secondary outcome [4]
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Fear of falling
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Assessment method [4]
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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
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Timepoint [4]
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Month 6 (middle of the follow-up period)
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Secondary outcome [5]
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Fear of falling
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Assessment method [5]
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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
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Timepoint [5]
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12 month re-assessment
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Secondary outcome [6]
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Fall risk awareness and behaviours
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Assessment method [6]
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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
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Timepoint [6]
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Week 3 (following the third training session)
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Secondary outcome [7]
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Fall risk awareness and behaviours
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Assessment method [7]
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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
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Timepoint [7]
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Month 6 (middle of the follow-up period)
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Secondary outcome [8]
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Fall Behavioural Scale
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Assessment method [8]
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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
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Timepoint [8]
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12 month re-assessment
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Secondary outcome [9]
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Anxiety
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Assessment method [9]
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Anxiety will be assessed using the General Anxiety Disorder - 7-item scale (Spitzer, 2006), a 21 point scale where higher scores indicate greater anxiety
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Timepoint [9]
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12 month re-assessment
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Secondary outcome [10]
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Physical activity levels
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Assessment method [10]
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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.
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Timepoint [10]
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12 month re-assessment
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Secondary outcome [11]
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Volitional Stepping Reaction time
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Assessment method [11]
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Volitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).
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Timepoint [11]
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12 month re-assessment
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Secondary outcome [12]
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Stepping inhibition
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Assessment method [12]
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Stepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.
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Timepoint [12]
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12 month re-assessment
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Secondary outcome [13]
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Catch-inhibition accuracy
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Assessment method [13]
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Catch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).
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Timepoint [13]
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12 month re-assessment
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Secondary outcome [14]
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Executive function
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Assessment method [14]
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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.
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Timepoint [14]
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12 month re-assessment
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Secondary outcome [15]
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Margin of stability
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Assessment method [15]
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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
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Timepoint [15]
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12 month re-assessment
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Secondary outcome [16]
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Extrapolated centre of mass
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Assessment method [16]
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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
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Timepoint [16]
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12 month re-assessment
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Secondary outcome [17]
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Step length
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Assessment method [17]
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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
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Timepoint [17]
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12 month re-assessment
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Secondary outcome [18]
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Range of trunk sway
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Assessment method [18]
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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
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Timepoint [18]
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12 month re-assessment
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Secondary outcome [19]
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Muscle activation onset latency (semitendinosus)
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Assessment method [19]
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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.
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Timepoint [19]
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12 month re-assessment
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Secondary outcome [20]
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Muscle activation onset latency (rectus femoris)
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Assessment method [20]
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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.
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Timepoint [20]
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12 month re-assessment
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Secondary outcome [21]
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Muscle activation amplitude (semitendinosus)
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Assessment method [21]
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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.
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Timepoint [21]
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12 month re-assessment
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Secondary outcome [22]
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Muscle activation amplitude (rectus femoris)
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Assessment method [22]
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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.
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Timepoint [22]
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12 month re-assessment
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Secondary outcome [23]
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Enjoyment of reactive balance training
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Assessment method [23]
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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.
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Timepoint [23]
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Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
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Secondary outcome [24]
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Adverse events during reactive balance training
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Assessment method [24]
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Adverse events such as muscle soreness, discomfort, pain or injury will be collected by staff during reactive balance training sessions.
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Timepoint [24]
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Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
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Eligibility
Key inclusion criteria
- Older persons - aged 65 years and older
- Community-dwelling
- Ability to walk 500m without rest or use of mobility aids
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/11/2023
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Sample size
Target
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Accrual to date
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Final
118
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04602858
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Lord, PhD
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Address
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Neuroscience Research Australia (NeuRA)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04602858
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