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Идёт набор NCT06270589

Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children

Без фазы С лечением Healthy Volunteers

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: MF-HIIT, MF-only, HIIT-only, Sitting rest.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers. Базовые параметры: 10 лет — 12 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function

Обзор

The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are: Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest Participants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities. Participants will complete the testing and/or receive treatments below: Day 1: * Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient * Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption) Days 2-5 * Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting) * Participants' heart rate and self-reported affect and rating of physical exertion will be measured * Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility * Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF. Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

Вмешательства

  • Поведенческое MF-HIIT
    A single bout of 20-min MF-HIIT protocol delivered through a motor-driven treadmill. The protocol will start with a 1.5-min warm-up, then a 16.5-min main exercise (6 x 90s exercise intervals separated by 5 x 90s mindful intervals), and finally a 2-min cool-down.
  • Поведенческое MF-only
    A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest
  • Поведенческое HIIT-only
    A single bout of 20-min HIIT protocol delivered through a motor-driven treadmill. The protocol will start with a 1.5-min warm-up, then a 16.5-min main exercise (6 x 90s exercise intervals separated by 5 x 90s rest intervals), and finally a 2-min cool-down.
  • Поведенческое Sitting rest
    Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.

Первичные конечные точки

  • Inhibition speed [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • Inhibition accuracy [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • Shifting speed [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • Shifting accuracy [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • N2-ERP [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • P3-ERP [Срок оценки: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
Вторичные конечные точки (3)
  • State Mindfulness Scale for Physical Activity (SMSPA) [Срок оценки: Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • Rating of perceived exertion [Срок оценки: Measure at 0 second, 90 seconds, 180 seconds, 270 seconds, 360 seconds, 450 seconds, 540 seconds, 630 seconds, 720 seconds, 810 seconds, 900 seconds, 990 seconds, 1080 seconds and 1200 seconds of the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]
  • Heart Rate [Срок оценки: Heart rate will be measured at every minute (minutes 0, 1, 2, 3, 4, ...., 18, 19, 20) during the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.]

Критерии участия

Критерии включения

  • Age between 10-12 years old
  • Intelligence Quotient ≥ 85
  • Capable of performing exercise based on pre-participation health screening
  • No formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)

Критерии исключения

  • Age outside of the range of 10-12 years old
  • Intelligence Quotient < 85
  • No capable of performing exercise based on pre-participation health screening
  • Has formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Lambert, 800 West Stadium Avenue — West Lafayette

Идентификаторы

NCT: NCT06270589 · IRB-2023-1684 · 1R21HD110656-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗