NCT06378164UnknownNot Applicable
The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial
The Hong Kong Polytechnic University1 site in 1 country98 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Choice Stepping Reaction Times
Study Overview
Brief Summary
To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Community-dwelling
- •Able to walk for 1 minute under supervision without walking aids
- •Have a history of falling in the past year
Exclusion Criteria
- •Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
- •Blindness
- •Neurological conditions (e.g., stroke, Parkinson's disease)
- •Other serious illnesses that preclude participation in exercise training
Arms & Interventions
Non-specific exercise group
Placebo Comparator
Intervention: Active Control (Behavioral)
Combined volitional and reactive step training
Experimental
Intervention: Exercise (Behavioral)
Outcomes
Primary Outcomes
Choice Stepping Reaction Times
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess volitional stepping performance
Spring Scale Test
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess reactive stepping performance
Secondary Outcomes
- Falls Efficacy Scale - International((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Trail-Making Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Prospective Falls(From start to 12 months after the intervention ends)
- Mini Balance Evaluation System Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Motor Control Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Programme Adherence(From start to six months after the end of training)
- Adverse Events(From start to six months after the end of training)
Investigators
Freddy Man Hin LAM
Assistant Professor
The Hong Kong Polytechnic University
Study Sites (1)
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