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Набор скоро начнётся NCT07738809

Effects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms

Без фазы С лечением Depressive Symptoms Sleep Disturbance

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: Archery Exercise, Non-exercise Control.
Кому может быть актуально
Состояния в реестре: Depressive Symptoms, Sleep Disturbance. Базовые параметры: 18 лет — 23 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Exercise Intervention on Sleep Quality, Emotional Problems, and Neuroelectrophysiological Mechanisms in College Students With Depressive Symptoms

Обзор

This exploratory randomized controlled trial aims to investigate the immediate and long-term effects of exercise on sleep quality, emotional problems, executive function, and neurophysiological characteristics in college students with depressive symptoms. The study consists of two sequential phases: an acute exercise experiment followed by an 8-week exercise intervention. Participants will be randomly assigned to either an exercise intervention group or a control group. Psychological questionnaires, behavioral tasks, resting-state electroencephalography (EEG), brain functional connectivity, and event-related potentials (ERP) will be assessed to evaluate behavioral and neurophysiological changes before and after exercise. The study will further examine whether the immediate response to acute exercise predicts the effectiveness of the long-term intervention.

Подробное описание

Depressive symptoms are highly prevalent among college students and are frequently accompanied by poor sleep quality, emotional disturbances, impaired executive function, and altered brain activity. Although physical exercise has been recognized as an effective non-pharmacological intervention for improving mental health, the neurophysiological mechanisms underlying these benefits remain unclear.

This study adopts an exploratory randomized controlled design consisting of two consecutive phases. In Phase I, participants will complete a single session of low-to-moderate intensity exercise to investigate immediate changes in emotional state, executive function, resting-state EEG, brain functional connectivity, and event-related potentials (ERP). In Phase II, the same participants will continue to participate in an 8-week exercise intervention to examine the effects of regular exercise on sleep quality, depressive symptoms, emotional problems, executive function, and neurophysiological characteristics.

Behavioral assessments, standardized psychological questionnaires, resting-state EEG, brain functional connectivity analysis, and ERP recordings will be performed before and after intervention. The study will also investigate whether the immediate response to acute exercise is associated with subsequent improvements following long-term exercise intervention, providing evidence for individualized exercise prescriptions and neurophysiological mechanisms of exercise in college students with depressive symptoms.

Вмешательства

  • Поведенческое Archery Exercise
    Participants perform a standardized archery exercise program consisting of an acute exercise session followed by an 8-week supervised training program. The acute session includes a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down. The long-term intervention is conducted three times per week for 8 weeks at moderate exercise intensity.
  • Поведенческое Non-exercise Control
    Participants continue their usual daily activities without participating in the archery exercise intervention.

Первичные конечные точки

  • Depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) [Срок оценки: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.]
  • Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.]
  • Resting-state EEG functional connectivity [Срок оценки: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.]

Критерии участия

Критерии включения

  • • Aged 18-23 years.
  • Right-handed.
  • Non-physical education major.
  • No history of psychiatric disorders and no current or previous use of psychotropic medications, hypnotics, or other medications affecting the central nervous system.
  • No history of traumatic brain injury or chronic physical diseases.
  • No contraindications to physical exercise.
  • Participants with a Beck Depression Inventory-II (BDI-II) score >13 will be classified as having depressive symptoms, whereas participants with a BDI-II score ≤13 will be classified as having no depressive symptoms.

Критерии исключения

  • Vigorous physical exercise, alcohol consumption, caffeine intake, or other stimulating behaviors within 24 hours before testing.
  • Withdrawal from the study before completion of EEG recording or behavioral task assessments.
  • Participants will be excluded from the final analysis if they fail to complete the required questionnaires or if the collected data do not meet predefined quality control criteria.

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
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai University of Sport — Шанхай

Идентификаторы

NCT: NCT07738809 · 2026A137

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗