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The SafeTrip Study - Step Training to Reduce Falls in Older Adults

Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04602858
Enrollment
118
Registered
2020-10-26
Start date
2020-12-01
Completion date
2023-11-19
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Fall Injury

Keywords

falls, fall prevention, balance, muscle, reflex, reactive balance

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.

Interventions

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.

OTHERControl

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.

Sponsors

The University of New South Wales
CollaboratorOTHER
Neuroscience Research Australia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Statistician blinded

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Older persons - aged 65 years and older * Community-dwelling * Ability to walk 500m without rest or use of mobility aids

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

Design outcomes

Primary

MeasureTime frameDescription
Laboratory induced falls12 month re-assessmentFall 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).
Trips in daily lifeThroughout 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.
Slips in daily lifeThroughout 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.

Secondary

MeasureTime frameDescription
Fear of fallingWeek 3 (following the third training session)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 risk awareness and behavioursWeek 3 (following the third training session)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
Fall Behavioural Scale12 month re-assessmentFall 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
Anxiety12 month re-assessmentAnxiety will be assessed using the General Anxiety Disorder - 7-item scale (Spitzer, 2006), a 21 point scale where higher scores indicate greater anxiety
Physical activity levels12 month re-assessmentPhysical 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.
Volitional Stepping Reaction time12 month re-assessmentVolitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).
Stepping inhibition12 month re-assessmentStepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.
Executive function12 month re-assessmentExecutive 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.
Margin of stability12 month re-assessmentMargin 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
Catch-inhibition accuracy12 month re-assessmentCatch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).
Step length12 month re-assessmentStep length during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Range of trunk sway12 month re-assessmentRange 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 onset latency (semitendinosus)12 month re-assessmentTime (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.
Muscle activation onset latency (rectus femoris)12 month re-assessmentTime (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.
Muscle activation amplitude (semitendinosus)12 month re-assessmentMuscle 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.
Muscle activation amplitude (rectus femoris)12 month re-assessmentMuscle 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.
Enjoyment of reactive balance trainingThroughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9Enjoyment 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.
Adverse events during reactive balance trainingThroughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9Adverse events such as muscle soreness, discomfort, pain or injury will be collected by staff during reactive balance training sessions.
Extrapolated centre of mass12 month re-assessmentExtrapolated 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
Falls in daily lifeThroughout 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.
Fall Risk12 month re-assessmentA 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).

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026