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临床试验/NCT06201533
NCT06201533
招募中
不适用

Effects of Low-intensity Exercise on Cognitive Function, Blood Biomarkers, and Metabolomic Alterations of Older Adults at Risk of Developing Dementia

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 64 人2024年4月7日

概览

阶段
不适用
干预措施
combined physical-cognitive exercise
疾病 / 适应症
Mild Cognitive Impairment
发起方
Chiang Mai University
入组人数
64
试验地点
1
主要终点
ADAS-Cog
状态
招募中
最后更新
2个月前

概览

简要总结

This study aims to examine the effects of low-intensity, combined physical-cognitive exercise on cognitive function of older people with mild cognitive impairment (MCI) and identify the mechanisms by which this exercise protocol exerts cognitive function. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. It is hypothesized that at the end of the trial, participants in the exercise group will demonstrate significant improvement in cognitive performance and circulating biomarkers compared to baseline and the control group.

详细描述

Accumulating evidence suggests that dementia may be preventable, especially at an early stage. Mild cognitive impairment (MCI), a preclinical phase of dementia, is a potentially reversible condition as several individuals with MCI could revert to normal level of cognition. Exercise has shown promising evidence of neurocognitive protection, however, not all studies reported such benefits. Type and intensity of exercise are two main factors that have often been accounted for discrepancies in previous findings. Based on previous evidence, low-intensity and combined physical-cognitive exercise might give the best result for cognitive enhancement. Thus, this study aims to examine the effects of low-intensity, combined physical-cognitive training on cognitive function of older people with MCI and identify the mechanisms by which this exercise protocol exerts cognitive function in individuals with MCI. A single-blinded, randomized controlled trial will be conducted. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. Outcome measures will be assessed at baseline and after a 3-month exercise. The primary outcome measures will be cognitive performance (specific and global cognitive function) and plasma brain-derived neurotrophic factor (BDNF). The secondary outcomes will include physical performance (functional mobility and strength), interleukin 6 (IL-6), fibroblast growth factor 21 (FGF21), and metabolomic profiles. Intention-to-treat method will be applied for data analyses.

注册库
clinicaltrials.gov
开始日期
2024年4月7日
结束日期
2026年3月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Somporn Sungkarat

Associate Professor

Chiang Mai University

入排标准

入选标准

  • meeting the criteria for MCI (or mNCD) based on the recent DSM-V criteria
  • comprehend instructions and able to comply with the study procedures
  • not taking any medications for their cognition and not planning to start medications during the study trial

排除标准

  • presence of medical condition(s) unsafe to exercise or affect cognition and mobility
  • presence of depressive symptoms
  • exercise regularly

研究组 & 干预措施

Low-intensity, combined physical-cognitive exercise

The exercise program will be prescribed at low intensity for 50 minutes/session, 3 times /week for 12 consecutive weeks.

干预措施: combined physical-cognitive exercise

Control

Participants will be asked to maintain their routine lifestyle throughout the study period.

结局指标

主要结局

ADAS-Cog

时间窗: 12 weeks

Alzheimer's Disease Assessment-cognitive subscale (ADAS-Cog) will be assessed at baseline and 12 weeks. The total scores range from 0-70 with higher scores indicating greater cognitive impairment.

Memory

时间窗: 12 weeks

Logical memory test will be evaluated at baseline and 12 weeks.

Plasma BDNF

时间窗: 12 weekss

Level of plasma brain-derived neurotrophic factor will be assessed at baseline and 12 weeks.

Executive function

时间窗: 12 weeks

Trail making test (TMT) part B-A will be evaluated at baseline and 12 weeks.

次要结局

  • Attention(12 weeks)
  • Plasma IL-6(12 weeks)
  • FGF21(12 weeks)

研究点 (1)

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