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Completed

NCT Number: NCT04602858

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

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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Key information

Conditions

Fall Fall Injury

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reactive Balance Training

Device

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.

Control

Other

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.

Primary outcomes

  1. Laboratory induced falls

    Time frame: 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).

  2. Trips in daily life

    Time frame: 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.

  3. Slips in daily life

    Time frame: 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.

Secondary outcomes

  1. Falls in daily life

    Time frame: 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.

  2. Fall Risk

    Time frame: 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).

  3. Fear of falling

    Time frame: Week 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

  4. Fear of falling

    Time frame: Month 6 (middle of the follow-up period)

    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

  5. Fear of falling

    Time frame: 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

  6. Fall risk awareness and behaviours

    Time frame: Week 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

  7. Fall risk awareness and behaviours

    Time frame: 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

  8. Fall Behavioural Scale

    Time frame: 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

  9. Anxiety

    Time frame: 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

  10. Physical activity levels

    Time frame: 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.

  11. Volitional Stepping Reaction time

    Time frame: 12 month re-assessment

    Volitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).

  12. Stepping inhibition

    Time frame: 12 month re-assessment

    Stepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.

  13. Catch-inhibition accuracy

    Time frame: 12 month re-assessment

    Catch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).

  14. Executive function

    Time frame: 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.

  15. Margin of stability

    Time frame: 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

  16. Extrapolated centre of mass

    Time frame: 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

  17. Step length

    Time frame: 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

  18. Range of trunk sway

    Time frame: 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

  19. Muscle activation onset latency (semitendinosus)

    Time frame: 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.

  20. Muscle activation onset latency (rectus femoris)

    Time frame: 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.

  21. Muscle activation amplitude (semitendinosus)

    Time frame: 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.

  22. Muscle activation amplitude (rectus femoris)

    Time frame: 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.

  23. Enjoyment of reactive balance training

    Time frame: 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.

  24. Adverse events during reactive balance training

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Neuroscience Research Australia

Other

Collaborators

  • The University of New South Wales

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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