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

NCT04602858 | Completed

• 2 other identifiers: HC190952U1111-1258-0513
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Fall Injury

Keywords

falls; fall prevention; balance; muscle; reflex; reactive balance

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (24)

• Falls in daily life

  Throughout a follow-up period (one year from randomisation)

• Fall Risk

  12 month re-assessment

• Fear of falling

  Week 3 (following the third training session)

• Fear of falling

  Month 6 (middle of the follow-up period)

• Fear of falling

  12 month re-assessment

Study Arms (2)

Reactive Balance Training

EXPERIMENTAL

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.

Device: Reactive Balance Training

Control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

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.

Reactive Balance Training

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuroscience Research Australia: lead
• The University of New South Wales: collaborator

Study Sites (1)

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Location

Study Officials

• Stephen Lord, PhD

  Neuroscience Research Australia (NeuRA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 26, 2020
• Study Start: December 1, 2020
• Primary Completion: November 19, 2023
• Study Completion: November 19, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Following publication of main study findings
• Access Criteria: Request should be made to the principal investigator and UNSW Human Research Ethics Committee which will be reviewed on a case-by-case basis

Locations

AU (1)