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Набор скоро начнётся NCT06317753

Can Exercise Rewire the Brain Addiction Circuitry?

Без фазы С лечением Physical Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aerobic Exercise, Agility-Cognitive Exercise, Stretching/relaxation.
Кому может быть актуально
Состояния в реестре: Physical Exercise. Базовые параметры: 18 лет — 24 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Aerobic Exercise
    Participants allocated to the Aerobic condition will be following a 4 month-intervention aerobic exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
  • Поведенческое Agility-Cognitive Exercise
    Participants allocated to the Agility-Cognitive condition will be following a 4 month-intervention agility-cognitive exercise protocol of 3 weekly interleaved sessions with a 50 minutes duration
  • Поведенческое Stretching/relaxation
    Participants allocated to the stretching control condition will be following a 4 month-intervention protocol of 1 weekly session with a 50 minutes duration

Первичные конечные точки

  • Behavioral: alcohol consumption [Срок оценки: Through study completion, an average of 1 year]
  • Behavioral: binge episodes [Срок оценки: Through study completion, an average of 1 year]
  • Behavioral : drunkenness [Срок оценки: Through study completion, an average of 1 year]
  • Psychological (craving levels) [Срок оценки: Through study completion, an average of 1 year]
  • Brain structure [Срок оценки: Through study completion, an average of 1 year]
  • Brain structural connectivity- FA [Срок оценки: Through study completion, an average of 1 year]
  • Brain structural connectivity - MD [Срок оценки: Through study completion, an average of 1 year]
  • Brain structural connectivity - AD [Срок оценки: Through study completion, an average of 1 year]
  • Brain structural connectivity - RD [Срок оценки: Through study completion, an average of 1 year]
  • Brain function [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (5)
  • Monetary Incentive Delay Task (included in the fMRI paradigm) - hits [Срок оценки: Through study completion, an average of 1 year]
  • Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time [Срок оценки: Through study completion, an average of 1 year]
  • Maximal oxygen consumption (VO2max) [Срок оценки: Through study completion, an average of 1 year]
  • Brain-derived neurotrophic factor (BDNF) [Срок оценки: Through study completion, an average of 1 year]
  • Dopamine [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06317753 · UMinho1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗