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RecruitingNCT06378164Updated Apr 22, 2024

The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers

An interventional study of Exercise and Active Control in Older Adults With a History of Falls, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Older Adults With a History of Falls

Keywords

  • Falls
  • Exercise
  • Randomised Trial
  • Step Training
  • Reaction
03

In context

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    Combined volitional and reactive step training

    Behavioral: Exercise

  • Placebo comparator
    Non-specific exercise group

    Behavioral: Active Control

Interventions

  • BehavioralExercise

    For the combined step training group, the participants will receive training on both volitional and reactive stepping. The training will last for 1 hours per session, 2 session per week for 4 weeks.

  • BehavioralActive Control

    An active control group will be used to minimise the placebo and history effect. The group will also receive a 4-week programme with the frequency and duration of the training and the instructor-to-participant ratio that match the combined step training group. During training, they will perform exercises not specific to reducing fall risk.

06

What researchers measure

Primary outcomes

  1. Choice Stepping Reaction Times

    To assess volitional stepping performance

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

  2. Spring Scale Test

    To assess reactive stepping performance

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

Secondary outcomes

  1. Mini Balance Evaluation System Test

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

  2. Motor Control Test

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

  3. Falls Efficacy Scale - International

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

  4. Trail-Making Test

    Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

  5. Programme Adherence

    The attendance of the exercise class will be recorded.

    Time frame: From start to six months after the end of training

  6. Prospective Falls

    Fall incidence and details on fall will be recorded using a fall diary and monthly follow-up.

    Time frame: From start to 12 months after the intervention ends

  7. Adverse Events

    Adverse events happened during the intervention will be recorded descriptively.

    Time frame: From start to six months after the end of training

07

Study locations

1 of 1 sites recruiting
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
    • Freddy Man Hin LAM, PhD · Contact · freddy-mh.lam@polyu.edu.hk · 27666720
    • Freddy Man Hin LAM · Contact
    • Freddy Man Hin LAM, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The study data can be provided via contacting the Principal Investigator

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06378164
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong, Neuroscience Research Australia, The University of New South Wales
Responsible party
Freddy Man Hin LAM (Assistant Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Apr 22, 2024
Start date
Dec 1, 2023
Primary completion
Apr 2025 (estimated)
Completion
Apr 2026 (estimated)
Last update
Apr 22, 2024

Study contacts

Freddy Man Hin LAM, PhD
Contact
freddy-mh.lam@polyu.edu.hk
2766 6720
Freddy Man Hin LAM, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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