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

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602858
• Other study ID #: HC190952
• Secondary ID: U1111-1258-0513
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: November 19, 2023

Study information

• Verified date: March 2024
• Source: Neuroscience Research Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 19, 2023
• Est. primary completion date: November 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Fall Injury

Intervention

Device:
• 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:
• 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.

Locations

Country	Name	City	State
Australia	Neuroscience Research Australia	Randwick	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Neuroscience Research Australia	The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory induced falls	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).	12 month re-assessment
Primary	Trips in daily life	Number of trips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.	Throughout a follow-up period (one year from randomisation)
Primary	Slips in daily life	Number of slips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.	Throughout a follow-up period (one year from randomisation)
Secondary	Falls in daily life	Number of falls in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.	Throughout a follow-up period (one year from randomisation)
Secondary	Fall Risk	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).	12 month re-assessment
Secondary	Fear of falling	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	Week 3 (following the third training session)
Secondary	Fear of falling	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	Month 6 (middle of the follow-up period)
Secondary	Fear of falling	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	12 month re-assessment
Secondary	Fall risk awareness and behaviours	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	Week 3 (following the third training session)
Secondary	Fall risk awareness and behaviours	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	Month 6 (middle of the follow-up period)
Secondary	Fall Behavioural Scale	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	12 month re-assessment
Secondary	Anxiety	Anxiety will be assessed using the General Anxiety Disorder - 7-item scale (Spitzer, 2006), a 21 point scale where higher scores indicate greater anxiety	12 month re-assessment
Secondary	Physical activity levels	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.	12 month re-assessment
Secondary	Volitional Stepping Reaction time	Volitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).	12 month re-assessment
Secondary	Stepping inhibition	Stepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.	12 month re-assessment
Secondary	Catch-inhibition accuracy	Catch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).	12 month re-assessment
Secondary	Executive function	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.	12 month re-assessment
Secondary	Margin of stability	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	12 month re-assessment
Secondary	Extrapolated centre of mass	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	12 month re-assessment
Secondary	Step length	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	12 month re-assessment
Secondary	Range of trunk sway	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	12 month re-assessment
Secondary	Muscle activation onset latency (semitendinosus)	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.	12 month re-assessment
Secondary	Muscle activation onset latency (rectus femoris)	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.	12 month re-assessment
Secondary	Muscle activation amplitude (semitendinosus)	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.	12 month re-assessment
Secondary	Muscle activation amplitude (rectus femoris)	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.	12 month re-assessment
Secondary	Enjoyment of reactive balance training	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.	Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Secondary	Adverse events during reactive balance training	Adverse events such as muscle soreness, discomfort, pain or injury will be collected by staff during reactive balance training sessions.	Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9