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临床试验/NCT05511259
NCT05511259已完成不适用

Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Nanyang Technological University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2022年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
N-Back task change

研究概览

简要总结

Brief Summary: The aim of this project is to examine:

  1. The effects of a community based square stepping exercise programme on cognitive and physical functions in older adults.
  2. The effects of a community based square stepping exercise programme on neuroplasticity in older adults.
  3. The effects of a community based square stepping exercise programme on structural and functional brain changes in older adults.
  4. The relationship between exercise-induced changes in neuroplasticity, structural and functional brain activations, and cognitive and physical gains in older adults.

详细描述

It is well known regular exercise produces both physical and cognitive benefits. Emerging evidence suggests that physical movements or exercise that have concurrent cognitive demands may have more profound effects on cognitive and brain health outcomes. One training program that incorporates these components is the square stepping exercise (SSE). First demonstrated in Japan, this community-based paradigm has already shown to reduce falls risk and presents as a convenient exercise modality for older adults, that can be conducted in a group setting or even the home. The current project aims to examine the efficacy of this SSE community programme in a Singapore context on cognitive and physical health in older adults. This study also aims to quantify the neural correlates underpinning any observed improvements in cognitive and physical function. Specifically, this project will measure indices of neuroplasticity via structural and functional magnetic resonance imaging, transcranial magnetic stimulation, and electroencephalography.

Sample size estimation: n=80 for behavioural primary outcome measures and n=40 subset of larger sample for neuroimaging and neuroplasticity secondary outcome measures [anticipated].

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Older adults aged 55-80
  • •Sedentary, defined as exercise less than 3 times per week for 30 minutes

排除标准

  • •Square stepping exercise:
  • •Medical conditions preventing them from movement and/or exercise
  • •Psychiatric conditions
  • •Cognitive impairment of dementia
  • •Upper and/or lower limb injuries in the past 6 months
  • •History of falls in the past 6 months
  • •Current smokers
  • •Neuroimaging (all the above in addition to the following)
  • •Patients who have conductive, ferromagnetic, or magnet-sensitive metals implanted in head (e.g., aneurysm clip, stent).
  • •Implanted medical device: e.g., cardiac implants, cochlear implant, aneurysm clips, cardiac pacemaker etc.
  • •Non-removable metal braces or retainer (dental fillings ok).
  • •Permanent tattoos on head.
  • •Deep brain stimulators.
  • •Previous brain surgery or injury.
  • •Patient with epilepsy or any other seizure history, or immediate family history of epilepsy.
  • •Clinical EEG that was abnormal or where seizure activity had not been ruled out.
  • •Patients with history of head injury with loss of consciousness are to be investigated about the history if/before being recruited.
  • •Diagnosis or possibility of neurological disorder (including stroke).
  • •Psychiatric condition.
  • •Major or unstable medical condition/surgery.
  • •Current or suspected pregnancy or lactation.
  • •Illicit drug use in the last 7 days.
  • •Alcohol use in the last 12 hours or more than 3 standard drinks in last 24 hours.
  • •Recent insomnia or severe sleep deprivation.
  • •Participation in another study involving brain stimulation (e.g., TMS, TDCS) in the past 7 days.

研究组 & 干预措施

Exercise-Cognition

Experimental

Square Stepping Exercise

干预措施: exercise (Other)

No exercise

No Intervention

Passive control group

结局指标

主要结局

N-Back task change

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

Number of correct responses (hits)

Static balance (single leg) change

时间窗: Baseline (week 0), post-intervention (week 13 after session 24)

Duration required to perform single leg stance on left and right legs

Modified Card Sorting task change

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

Total number of perseverative errors

Motor learning change

时间窗: Baseline (week 0), post-intervention (week 13 after session 24)

Probabilistic Serial Reaction Time Task: learning index, computed using reaction time

Go-No-Go task change

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

Error rate: Number of "Go" responses on "No-Go" trials.

Stroop task colour words and colour blocks

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

Average response time (reaction time) for the correct colour word incongruent trials.

Trail Making Test ((TMT) change

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

B:A: Divide the time taken for TMT B by TMT A

Digit Span task change

时间窗: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

Maximum accurate span length for Digit Span Forward Maximum accurate span length for Digit Span Reverse

Temporal gait parameters change

时间窗: Baseline (week 0), post-intervention (week 13 after session 24)

11-meter gait test to examine gait speed

次要结局

  • Brain plasticity changes(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in white matter integrity(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in grey matter volume(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in structural topography(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in functional connectivity(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in cortical thickness(Baseline (week 0), post-intervention (week 13 after session 24))
  • Change in white matter connectivity(Baseline (week 0), post-intervention (week 13 after session 24))

研究者

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

SH Annabel Chen, PhD

Professor of Psychology, School of Social Sciences

Nanyang Technological University

研究点 (1)

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