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临床试验/NCT06317753
NCT06317753尚未招募不适用

Can Exercise Rewire the Brain Addiction Circuitry? A Randomized Trial of Exercise and Binge Drinking

University of Minho0 个研究点目标入组 60 人开始时间: 2026年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Behavioral: binge episodes

研究概览

简要总结

The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD.

详细描述

The proposed research plan focuses on the identification of changes in the structural and functional brain parameters (e.g. volume, brain activity), in response to a physical exercise (PE) protocol, on the neurocircuitry of addiction, after a 4 month-intervention program in college binge drinkers (BDs). The main objectives of this proposal are: O1) to evaluate the potential benefits of PE on the brain structure and function, particularly in the neurocircuitry of addiction, in a sample of Portuguese college students with a binge drinking pattern of alcohol use; and O2) to determine whether the PE intervention reduces craving and alcohol consumption levels in BDs. The present project will involve: i) a pre-intervention comprehensive evaluation of behavioral (alcohol consumption), psychological (craving levels), physiological (VO2, HRV), and neurological (neuroimaging) variables; ii) a training phase consisting of 48 sessions (3 weekly sessions*16 weeks) of aerobic (exp group 1), agility-cognitive (exp group 2) exercise and stretching (control group; iii) a post-intervention evaluation of behavioral, physiological, and neurological (neuroimaging) variables; iv) and a 6 months' follow- up evaluation of behavioral, physiologicaln and cognitive variables. A randomized controlled trial will be implemented at the University of Minho. It will include a total of 60 college students with a binge drinking pattern of alcohol intake, 20 participants per condition.

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
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • binge drinking > or = 5 ; > or =4 for women alcoholic drinks
  • in the same time window (±2h)
  • at least once per month
  • <150 minutes of physical activity per week

排除标准

  • Major and/or unstable medical conditions
  • Physical limitations that may constraint the practice of exercise
  • Cardiovascular and respiratory insufficiency
  • History of traumatic brain injury or neurological disorder
  • Non-corrected sensory deficits
  • Personal history of psychopathological disorders
  • Family history of alcoholism or substance abuse in first degree relatives
  • Consumption of medical drugs with psychoactive effects (e.g., sedatives or anxiolytics) during the month previous to the assessment
  • Use of illegal drugs and AUDIT scores >20
  • MRI contraindications
  • Current or previous (past year) participation in a physical exercise program

研究组 & 干预措施

Control condition

Active Comparator

Participants allocated to the Control condition will be following a stretching/relaxation training program.

干预措施: Stretching/relaxation (Behavioral)

Experimental condition 1

Experimental

Participants allocated to the Experimental condition 1 will be following a aerobic exercise training program.

干预措施: Aerobic Exercise (Behavioral)

Experimental condition 2

Experimental

Participants allocated to the Experimental condition 2 will be following an agility-cognitive exercise training program.

干预措施: Agility-Cognitive Exercise (Behavioral)

结局指标

主要结局

Behavioral: binge episodes

时间窗: Through study completion, an average of 1 year

Number of binge drinking episodes

Psychological (craving levels)

时间窗: Through study completion, an average of 1 year

Scores in the Alcohol Craving Questionnaire (The cutoff points for total scale points are: 12-17 = minimal desire, 18-25 = mild, 26-42 = moderate and 43 or more = severe)

Brain structural connectivity - MD

时间窗: Through study completion, an average of 1 year

Structural connectivity-mean diffusivity-a scalar measure between zero and one that describes the total diffusion within a voxel

Brain structural connectivity - RD

时间窗: Through study completion, an average of 1 year

Structural connectivity-radial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.

Behavioral : drunkenness

时间窗: Through study completion, an average of 1 year

Percentage of drunkenness

Brain structure

时间窗: Through study completion, an average of 1 year

Structure-volume in liters

Brain structural connectivity - AD

时间窗: Through study completion, an average of 1 year

Structural connectivity-axial diffusivity-a scalar measure between zero and one within a voxel that describes the magnitude of diffusion parallel to fiber tracts.

Brain function-resting state

时间窗: Through study completion, an average of 1 year

Functional connectivity for resting-state fMRI

Brain structural connectivity- FA

时间窗: Through study completion, an average of 1 year

Structural connectivity-fractional anisotropy-scalar value between zero and one within a voxel that describes the degree of anisotropy of a diffusion process

Behavioral: alcohol consumption

时间窗: Through study completion, an average of 1 year

Number of drinks per binge drinking episode

Brain function

时间窗: Through study completion, an average of 1 year

Bold signal for Task-related fMRI

次要结局

  • Monetary Incentive Delay Task (included in the fMRI paradigm) - hits(Through study completion, an average of 1 year)
  • Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time(Through study completion, an average of 1 year)
  • Brain-derived neurotrophic factor (BDNF)(Through study completion, an average of 1 year)
  • Dopamine(Through study completion, an average of 1 year)
  • Maximal oxygen consumption (VO2max)(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonia Sousa

Principal Investigator

University of Minho

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