跳至主要内容
临床试验/NCT06828926
NCT06828926招募中不适用

Project Gnosis: the Neural, Physical, and Psychosocial Processes and Health Outcomes of an 8-week Tai Chi Intervention in Older Adults with and Without Mild Cognitive Impairment

Ohio University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Executive Function - Stroop Color-Word Interference Test

研究概览

简要总结

Mild Cognitive Impairment (MCI) in older adults is linked to muscle loss (sarcopenia) and can lead to dementia, with pain further impacting cognitive and physical performance. Tai Chi, a mind-body exercise, is recommended for managing MCI as it supports cognitive function, mood, and physical health.

The investigators' first goal is to characterize the correlation of heart rate variability and cortical activity on cognitive function and the psychosocial correlates of pain interference and social isolation on cognitive function at baseline and post-intervention (8 weeks of Tai Chi). The second goal is to explain the role of sarcopenia and obesity in the relationship between pain interference and cognitive function. The investigators also want to examine the index of the predictive capacity regarding sarcopenia and obesity on cognitive function outcomes.

研究设计

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

入排标准

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

入选标准

  • Participants who are older adults, defined as ≥60 years old.
  • Participants must have the ability to independently stand without the use of an assistive device for 20 minutes.
  • People with Mild Cognitive Impairment (MCI) (initial cohort) and without MCI (age-gender matched healthy controls). A score of between >18 and ≤26 on the Montreal Cognitive Assessment (MoCA) will be used to classify MCI. A score above 26 is considered normal.

排除标准

  • Participants with significant uncontrolled medication, and cardiovascular, respiratory, and metabolic symptoms will be excluded from participation in the study, as these symptoms could impact their engagement with the engagement of Tai Chi.
  • Investigators will administer a brief screening questionnaire to assess (a) hypotension symptoms related to intensive treatment of hypertension and (b) hypoglycemia related to intensive treatment of diabetes, as these conditions are associated with cognitive decline.
  • Investigators will capture data on potential sleep apnea and administer the Stop-Bang Questionnaire to identify potential sleep-disordered breathing. Participants with significant uncontrolled sleep apnea will be excluded as this could also impact their engagement in the intervention and influence the primary outcome measure of cognitive function.
  • Currently or recently practicing Tai Chi. Participants will be excluded if they are currently practicing Tai Chi. If participants have previously engaged in Tai Chi, there will be a washout period of at least 6 months before considering enrollment in the study.

结局指标

主要结局

Executive Function - Stroop Color-Word Interference Test

时间窗: From enrollment to the end of treatment at 8 weeks

Delis-Kaplan Executive Function System Stroop Color-Word Interference Test

Executive Function - Semantic Fluency Test

时间窗: From enrollment to the end of treatment at 8 weeks

Repeatable Battery for the Assessment of Neuropsychological Status - Semantic Fluency Test

次要结局

  • Cognitive Function - Processing Speed(From enrollment to the end of treatment at 8 weeks)
  • Positive Affect(From enrollment to the end of treatment at 8 weeks)
  • Meaning and Purpose(From enrollment to the end of treatment at 8 weeks)
  • Heart Rate Variability(From enrollment to the end of treatment at 8 weeks)
  • Cortical activity(From enrollment to the end of treatment at 8 weeks)
  • Pain Interference(From enrollment to the end of treatment at 8 weeks)
  • Social Isolation(From enrollment to the end of treatment at 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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