跳至主要内容
临床试验/NCT05655403
NCT05655403招募中不适用

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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
145
试验地点
1
主要终点
Choice stepping reaction time test (CSRTT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Step training program (Behavioral)

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.

干预措施: Step training program (Behavioral)

结局指标

主要结局

Choice stepping reaction time test (CSRTT)

时间窗: 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.

次要结局

  • Maximum step length test (MSLT)(Post-intervention (week 12))
  • Berg Balance Scale (BBS)(Post-intervention (week 12))
  • 30-second sit-to-stand test (30STS)(Post-intervention (week 12))
  • Prefrontal cortex (PFC) functioning during choice stepping(Post-intervention (week 12))
  • Iconographical Fall Efficacy Scale - Chinese version (Icon-FES)(Post-intervention (week 12))
  • Timed Up and Go Single Task (TUG-S) and Timed Up and Go Dual Task (TUG-D)(Post-intervention (week 12))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wayne Chan

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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