Effects of Step Training in Older Adults with Mild Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Step training program.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Behavioral Step training program
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
Primary outcome measures
- Choice stepping reaction time test (CSRTT) [Time frame: Post-intervention (week 12)]
Secondary outcome measures (6)
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT05655403 · 20221201007