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Clinical Trial Summary

Most research on the effects of regular exercise on cognitive and brain functions has been focused on exercise programs with a single mode of exercise. Studies focusing on the effects of exercise programs with multi-domains on cognitive function and cortical functionality are sparse in late-middle-aged and older adults. Therefore, the current project will utilize a single-blinded, double arm, 6-month randomized controlled trial to assess the effects of a multi-domain exercise program containing multiple physical fitness components, meditation, and social interaction on memory performance, as well as cortical activities during the memory tasks in cognitively intact adults (i.e., 45-70 years). In addition, the potential moderator role of apolipoprotein epsilon-4 (ApoE e4) status and the mediator role of the serum biomarkers (i.e., brain-derived neurotrophic factor, BDNF) will be explored.


Clinical Trial Description

Aging has been adversely associated with the deterioration of cognitive and brain functions. Most research on the effects of regular exercise on cognitive and brain functions has been focused on exercise programs with a single mode of exercise. Studies focusing on the effects of exercise programs with multi-domains on cognitive function and cortical functionality are sparse in late-middle-aged and older adults. In addition, while growing evidence has revealed the beneficial effects of regular exercise on cognitive function, scientific evidence regarding the effects of multi-domain exercise programs on cognitive function and brain function in late-middle-aged and older adults who are with or without the genetic risk for Alzheimer's disease (AD) is scarce. Lastly, the potential mediator role of the levels of the serum biomarkers (i.e., brain-derived neurotrophic factor, BDNF) in individuals is required to be explored. In the current study, a single-blinded, double arm, 6-month randomized controlled trial will be utilized to assess the effects of a multi-domain exercise program containing multiple physical fitness components, meditation, and social interaction on memory, as well as cortical functionalities during the memory tasks in cognitively intact adults (i.e., 45-70 years) . Specifically, the investigators aim to examine: (1) the causal links between a multi-domain exercise program composing of various physical fitness components, meditation, and social interaction against an active control group on the memory performance in cognitively intact adults aged between 45 and 70 years with or without a genetic risk for AD, (2) the cortical functionality through functional images collected through a series of functional magnetic resonance images (fMRI), and (3) the potential influence of apolipoprotein epsilon-4 (ApoE e4) and BDNF on the effects of exercise. One hundred eligible participants will participate in the current study and will be randomly assigned into either the 6-month multi-domain exercise group (exercise group) or the online educational course group (active control group). In each group, the ages ratio (≤ 55 years vs. > 55 years), and ApoE genotype [i.e., High-risk candidates (ApoE e3/e4 and ApoE e4/e4) vs. the Low-risk candidates (ApoE e2/e4, ApoE e2/e3, ApoE e2/e2 and ApoE e3/e3)] will be in a ratio of 1:1. Participants in the exercise and the active control groups would receive either the two 90-min exercise sessions or online educational courses per week, respectively. All participants' physical fitness, cognitive function, and cortical functionalities via fMRI scanning will be assessed at the Baseline (Baseline-Assessments) and at the cessation of the 6-month intervention (Post-Assessments). The potential moderating role of ApoE genotypes and the mediation role of BDNF will be explored. Participation in this study will take approximately 7 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05068271
Study type Interventional
Source National Taiwan Normal University
Contact Yu-Kai Chang, PhD
Phone +886277493220
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date March 2022
Completion date September 2025

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