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临床试验/NCT06127667
NCT06127667招募中不适用

Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan

University of Minnesota1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年10月15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
102
试验地点
1
主要终点
Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.

研究概览

简要总结

This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
  • •the absence of major orthopedic disability
  • •cognitively normal (MoCA score ≥ 26/30 in older adult group)
  • •vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
  • •English speaking
  • •ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.

排除标准

  • •insulin-dependent diabetes
  • •peripheral neuropathy
  • •myocardial infarction or symptoms of coronary artery disease within 2 years
  • •congestive heart failure or class IV heart failure
  • •any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.

研究组 & 干预措施

Experimental group

Experimental

Healthy participants in 3 age groups

干预措施: aerobic exercise (Behavioral)

结局指标

主要结局

Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.

时间窗: 1 week

Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.

Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG

时间窗: 1 week

Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.

cerebral blood flow velocity assessed using transcranial Doppler ultrasound

时间窗: 1 week

Includes recordings from transcranial Doppler ultrasound of cerebral blood flow (CBF) velocity performed at the first session during rest, sit-to-stand, transfer, and single bout of aerobic exercise.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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