NCT05655403 Effects of Step Training in Older Adults with Mild Dementia
| NCT ID | NCT05655403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 145 participants in total. It began in 2024-01-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Step training has been shown to be effective at reducing the incidence of falls and improving related risk factors, including choice stepping, in healthy older adults. However, the effects of step training have not been investigated in OWMD. The primary objective of the proposed project will be to assess the effects of a step-training program involving concurrent stepping and visuospatial tasks on choice stepping, prefrontal cortex functioning during choice stepping, and fall-related outcomes (i.e., step length, lower-limb muscle strength, balance, mobility, dual-task ability, and fear of falling) in OWMD. The prefrontal cortex is responsible for the executive functions such as attention and inhibitory function, which are integral to choice stepping reaction time tasks. However, the effects of step training on prefrontal cortex functioning during choice stepping in OWMD remain unclear. The neural mechanisms underlying the potential effects of step training on choice stepping have never been investigated in this population. Therefore, the secondary objective of the proposed project will be to evaluate the mediating effects of changes in the prefrontal cortex functioning during choice stepping on the potential benefits of a step-training program for choice stepping in OWMD. The proposed project will provide robust evidence to support the use of step training to improve choice stepping and reduce the risk of falls in OWMD. Disentangling the neural mechanisms underlying the effects of step training will be crucial to the development of the most effective interventions to target these mechanisms.
Eligibility Criteria
Inclusion Criteria: * at least 65 years old; * have a physician's diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition; * have mild dementia, indicated by a score of 10 or higher on the Montreal Cognitive Assessment Hong Kong version (HK-MoCA); * able to walk 10 meters independently without a walking aid; * receiving care by an unpaid "main caregiver" with at least 3.5 hours of face-to-face contact per week. Exclusion Criteria: * unable to perform step training due to unstable or severe musculoskeletal, cardiorespiratory, or neurological conditions; * have severe hearing and/or visual impairments that limit their ability to communicate; * have been hospitalized within the past 30 days.
Contact & Investigator
Wayne LS Chan, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05655403 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05655403 currently recruiting?
Yes, NCT05655403 is actively recruiting participants. Contact the research team at wayne.ls.chan@polyu.edu.hk for enrollment information.
Where is the NCT05655403 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05655403 clinical trial?
NCT05655403 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Wayne LS Chan, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 145 participants.