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

NCT ID: NCT04602858

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-11-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Reactive Balance Training

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.

Group Type: EXPERIMENTAL

Reactive Balance Training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of New South Wales

OTHER

Sponsor Role: collaborator

Neuroscience Research Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Lord, PhD

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Research Australia (NeuRA)

Locations

Neuroscience Research Australia

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

U1111-1258-0513

Identifier Type: OTHER

Identifier Source: secondary_id

HC190952

Identifier Type: -

Identifier Source: org_study_id