DementiaNCT05655403
Effects of Step Training in Older Adults with Mild Dementia
A study testing Step training program in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Step training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Wayne LS Chan, PhD, +852 27666742, wayne.ls.chan@polyu.edu.hk
About this study
Official title: Investigating the Effects of Step Training and the Mediating Effects of Prefrontal Cortex Functioning in Older Adults with Mild Dementia: a Randomized Wait-list Controlled Trial
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.
Read the detailed description
Falls are common in older adults with mild dementia (OWMD), and they are the leading cause of functional dependence, morbidity, and mortality in this population. The ability to take rapid, accurate, and effective steps in varied environmental conditions, such as walking on a wet floor or rough terrain, is crucial to ensuring safety and avoiding falls. OWMD often have difficulties in choice stepping (i.e., stepping on a specific target, while avoiding irrelevant distractions), which requires high levels of sensorimotor and cognitive function. As impaired choice stepping has been shown to predict falls in the general older population, improving choice stepping is expected to reduce the risk of falls in OWMD.
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. Furthermore, the scientific evidence derived from the proposed project will motivate patients, caregivers, and clinicians to participate in such programs, and subsequently, relieve the fall-related burdens on multiple stakeholders.
- Conditions
- Dementia
- Being tested
- Step training program
- Keywords
- Step training, Falls, Dementia, Randomized controlled trial, Prefrontal cortex
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step training programBehavioural
The program will consist of 3 phases: (1) getting familiar, (2) increasing complexity, and (3) consolidating skills. In Phase 1, the participants will be asked to use one foot to step on single-colored stepping panels located in a specific region of the plastic mat (e.g., upper quadrant). In Phase 2, the exercise will progress by introducing the following 4 cognitively challenging stepping tasks. After finishing the 4 stepping tasks in Phase 2, the exercises will progress to Phase 3, which will consolidate the participants' stepping and cognitive skills. The following 4 additional stepping tasks will be introduced. The instructor will tailor the exercises for each participant, based on their training performance.
| Study group | Role | What they receive |
|---|---|---|
| Step training group | Experimental | The participants assigned to the ST condition will receive a 40-minute ST session twice a week for 12 weeks. The sessions will be delivered at community centers for older adults by an instructor with at least 5 years of experience in dementia care. Each session will consist of a 5-minute flexibility exercise warm-up, a 30-minute stepping exercise, and a 5-minute cool-down. A non-slip plastic mat marked with two standing panels and a number of removable stepping panels that can be secured to the plastic mat using hook-and-loop fasteners will be used as the exercise device. While standing on the standing panels, the participants will receive verbal instructions to (1) use one of their feet to step on a specific stepping panel and (2) return the stepping foot to the standing panel multiple times throughout every session. Receives: Behavioral: Step training program |
| Wait-list control group | Active comparator | The participants assigned to the WC condition will then receive usual care for 12 weeks. After completing the 12-week assessment, they will complete the ST program. Receives: Behavioral: Step training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice stepping reaction time test (CSRTT)
Participants will be asked to stand on a non-slip plastic mat marked with two standing panels and four stepping panels. The RA will provide verbal instructions to (1) use one foot to step on a stepping panel to the front or the side and (2) return the stepping foot to the standing panel. The participants will complete 20 stepping trials as quickly as possible based on a fixed pre-determined sequence. The first 8 trials will be regarded as practice trials. The total time to complete the last 12 trials will be measured in seconds using a stopwatch.
Measured: Post-intervention (week 12)
Secondary outcomes (6)
Prefrontal cortex (PFC) functioning during choice stepping
fNIRS will be used to measure PFC activity during stepping tasks. Participants will be asked to stand on the same plastic mat used in the CSRTT. They will be asked to finish 2 rounds of stepping tasks, with 8 stepping blocks in each round and 8 stepping trials per block (i.e., active periods). The stepping performance of the participants will be videotaped using a handheld camera, and the number of correct and incorrect steps taken according to the verbal cues provided will be counted.
Each stepping round will consist of 4 simple and 4 choice stepping blocks. In the simple stepping block, the participants will be verbally instructed to use the same foot to repeatedly step on the same panel. In the choice stepping block, they will be asked to use either the left or right foot to step on different panels in each trial.
Measured: Post-intervention (week 12)
Maximum step length test (MSLT)
Participants will be asked to use their left or right foot to step 1) forward, (2) sideways, and (3) backward as far as they can without losing their balance. The mean distance covered in 5 stepping trials for each foot and direction will be recorded separately.
Measured: Post-intervention (week 12)
30-second sit-to-stand test (30STS)
Participants will be asked to repeatedly rise from a chair and sit down. The number of repetitions completed in 30 seconds will be recorded.
Measured: Post-intervention (week 12)
Berg Balance Scale (BBS)
The BBS consists of 14 items measuring the balance performance during daily functional activities, such as chair transfer, standing with eyes closed, turning 360 degrees, tandem standing, and single-leg standing. The total score ranges from 0 to 56, with a higher score indicating better balance.
Measured: Post-intervention (week 12)
Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)
The Icon-FES uses a combination of illustrations to assess concerns about falling during 10 daily activities, such as changing clothes, taking a shower, and changing a light bulb. The total score ranges from 0 to 40, with a higher score indicating a greater fear of falling.
Measured: Post-intervention (week 12)
Timed Up and Go Single Task (TUG-S) and Timed Up and Go Dual Task (TUG-D)
In the TUG-S, the participants will be instructed to rise from an armchair, walk 3 meters, turn 180 degrees, walk back to the chair, and sit down at their own pace, and the time taken to complete the task will be recorded. For the TUG-D, the participants will be asked to perform the TUG-S while simultaneously naming as many animals as possible. The time used to complete the TUG-D and the dual-task cost (i.e., the time difference between the TUG-D and TUG-S) will be recorded.
Measured: Post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Responsible party
- Principal investigator, Dr. Wayne Chan, The Hong Kong Polytechnic University
- Investigators
- Wayne LS Chan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655403
- Sponsor's protocol ID
- 20221201007
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Step Training and the Mediating Effects of Prefrontal Cortex Functioning in Older Adults with Mild Dementia: a Randomized Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT05655403
- Acronym / sponsor ID
- 20221201007
- Conditions
- Dementia
- Keywords
- Step training, Falls, Dementia, Randomized controlled trial, Prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls are common in older adults with mild dementia (OWMD), and they are the leading cause of functional dependence, morbidity, and mortality in this population. The ability to take rapid, accurate, and effective steps in varied environmental conditions, such as walking on a wet floor or rough terrain, is crucial to ensuring safety and avoiding falls. OWMD often have difficulties in choice stepping (i.e., stepping on a specific target, while avoiding irrelevant distractions), which requires high levels of sensorimotor and cognitive function. As impaired choice stepping has been shown to predict falls in the general older population, improving choice stepping is expected to reduce the risk of falls in OWMD.
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. Furthermore, the scientific evidence derived from the proposed project will motivate patients, caregivers, and clinicians to participate in such programs, and subsequently, relieve the fall-related burdens on multiple stakeholders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step training group | Experimental | Behavioral: Step training programThe participants assigned to the ST condition will receive a 40-minute ST session twice a week for 12 weeks. The sessions will be delivered at community centers for older adults by an instructor with at least 5 years of experience in dementia care. Each session will consist of a 5-minute flexibility exercise warm-up, a 30-minute stepping exercise, and a 5-minute cool-down. A non-slip plastic mat marked with two standing panels and a number of removable stepping panels that can be secured to the plastic mat using hook-and-loop fasteners will be used as the exercise device. While standing on the standing panels, the participants will receive verbal instructions to (1) use one of their feet to step on a specific stepping panel and (2) return the stepping foot to the standing panel multiple times throughout every session. |
| Wait-list control group | Active comparator | Behavioral: Step training programThe participants assigned to the WC condition will then receive usual care for 12 weeks. After completing the 12-week assessment, they will complete the ST program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step training programThe program will consist of 3 phases: (1) getting familiar, (2) increasing complexity, and (3) consolidating skills. In Phase 1, the participants will be asked to use one foot to step on single-colored stepping panels located in a specific region of the plastic mat (e.g., upper quadrant). In Phase 2, the exercise will progress by introducing the following 4 cognitively challenging stepping tasks. After finishing the 4 stepping tasks in Phase 2, the exercises will progress to Phase 3, which will consolidate the participants' stepping and cognitive skills. The following 4 additional stepping tasks will be introduced. The instructor will tailor the exercises for each participant, based on their training performance. | Behavioural | Step training group, Wait-list control group |
Primary outcome
Choice stepping reaction time test (CSRTT)
Time frame: Post-intervention (week 12)
Participants will be asked to stand on a non-slip plastic mat marked with two standing panels and four stepping panels. The RA will provide verbal instructions to (1) use one foot to step on a stepping panel to the front or the side and (2) return the stepping foot to the standing panel. The participants will complete 20 stepping trials as quickly as possible based on a fixed pre-determined sequence. The first 8 trials will be regarded as practice trials. The total time to complete the last 12 trials will be measured in seconds using a stopwatch.
6 secondary outcomes
Prefrontal cortex (PFC) functioning during choice stepping
Time frame: Post-intervention (week 12)
Maximum step length test (MSLT)
Time frame: Post-intervention (week 12)
30-second sit-to-stand test (30STS)
Time frame: Post-intervention (week 12)
Berg Balance Scale (BBS)
Time frame: Post-intervention (week 12)
Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)
Time frame: Post-intervention (week 12)
Timed Up and Go Single Task (TUG-S) and Timed Up and Go Dual Task (TUG-D)
Time frame: Post-intervention (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wayne LS Chan, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step training program in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wayne LS Chan, PhD (+852 27666742, wayne.ls.chan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice stepping reaction time test (CSRTT) (time frame: Post-intervention (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.