Clinical trial NCT04602858: The SafeTrip Study - Step Training to Reduce Falls in Older Adults
Official title: Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Fall Injury
Keywords: falls
fall prevention
balance
muscle
reflex
reactive balance
Lead sponsor: Neuroscience Research Australia
Sponsor class: OTHER
Collaborators: name: The University of New South Wales
First posted: 2020-10-26
Enrollment: 118
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Laboratory induced falls
timeFrame: 12 month re-assessment
measure: Trips in daily life
timeFrame: Throughout a follow-up period (one year from randomisation)
measure: Slips in daily life
timeFrame: Throughout a follow-up period (one year from randomisation)
Secondary outcomes:
measure: Falls in daily life
timeFrame: Throughout a follow-up period (one year from randomisation)
measure: Fall Risk
timeFrame: 12 month re-assessment
measure: Fear of falling
timeFrame: Week 3 (following the third training session)
measure: Fear of falling
timeFrame: Month 6 (middle of the follow-up period)
measure: Fear of falling
timeFrame: 12 month re-assessment
measure: Fall risk awareness and behaviours
timeFrame: Week 3 (following the third training session)
measure: Fall risk awareness and behaviours
timeFrame: Month 6 (middle of the follow-up period)
measure: Fall Behavioural Scale
timeFrame: 12 month re-assessment
measure: Anxiety
timeFrame: 12 month re-assessment
measure: Physical activity levels
timeFrame: 12 month re-assessment
measure: Volitional Stepping Reaction time
timeFrame: 12 month re-assessment
measure: Stepping inhibition
timeFrame: 12 month re-assessment
measure: Catch-inhibition accuracy
timeFrame: 12 month re-assessment
measure: Executive function
timeFrame: 12 month re-assessment
measure: Margin of stability
timeFrame: 12 month re-assessment
measure: Extrapolated centre of mass
timeFrame: 12 month re-assessment
measure: Step length
timeFrame: 12 month re-assessment
measure: Range of trunk sway
timeFrame: 12 month re-assessment
measure: Muscle activation onset latency (semitendinosus)
timeFrame: 12 month re-assessment
measure: Muscle activation onset latency (rectus femoris)
timeFrame: 12 month re-assessment
measure: Muscle activation amplitude (semitendinosus)
timeFrame: 12 month re-assessment
measure: Muscle activation amplitude (rectus femoris)
timeFrame: 12 month re-assessment
measure: Enjoyment of reactive balance training
timeFrame: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
measure: Adverse events during reactive balance training
timeFrame: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: Neuroscience Research Australia (NeuRA)
name: Stephen Lord, PhD
role: PRINCIPAL_INVESTIGATOR
References: