Effects of Step Training in Older Adults with Mild Dementia

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Dementia

Treatments: Behavioral: Step training program

Study type: Interventional

Funder types: Other

Identifiers

NCT05655403

20221201007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups

Step training group

Experimental group

Description:

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.

Treatment:

Behavioral: Step training program

Wait-list control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Step training program