跳至主要内容
临床试验/NCT05446909
NCT05446909已完成不适用

Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline

Arizona State University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Percentage of Trials Correct On Working Memory Test

研究概览

简要总结

The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

详细描述

Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).

研究设计

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

入排标准

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

入选标准

  • Able to read/understand English
  • Normal performance using standardized cognitive tests
  • Self-reported decline in cognitive capacity such as memory loss
  • Eligible for non-invasive fMRI
  • Willing to be randomized
  • Free of any severe psychiatric diagnoses or medication that may affect participation

排除标准

  • Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
  • Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
  • Previous meditation experiences
  • Evidence of illicit drug use
  • Participants for blood draws weigh less than 110 lbs
  • Metal or metallic materials in the body such as pacemaker

结局指标

主要结局

Percentage of Trials Correct On Working Memory Test

时间窗: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.

Intervention Effects on Cognitive Decline

时间窗: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.

Intervention Effects on Emotion Regulation

时间窗: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

The composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome.

Intervention Effects on Mindfulness

时间窗: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

The composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (1 and 5); higher scores mean a better outcome.

次要结局

  • Intervention Effects on Brain Function(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)
  • Intervention Effects on Brain White Matter(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)
  • Intervention Effects on Brain Grey Matter(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验