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临床试验/NCT06258941
NCT06258941招募中1 期

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

Purdue University2 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2025年2月14日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
352
试验地点
2
主要终点
Updating speed

研究概览

简要总结

The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities.

Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases.

During the pretest phase, participants an their parents will complete the following

  1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
  2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
  3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
  4. Computerized tasks to assess EF
  5. Parent-reported demographic and health information

Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit.

Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again.

Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

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
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 8-12 years old
  • Intelligence Quotient ≥ 70
  • Capable of performing exercise based on pre-participation health screening
  • No formal diagnosis of neurological diseases (e.g., epilepsy)

排除标准

  • Age outside of the range of 8-12 years old
  • Intelligence Quotient < 70
  • No capable of performing exercise based on pre-participation health screening
  • Has formal diagnosis of neurological diseases (e.g., epilepsy)

研究组 & 干预措施

12-Week Mindful High-Intensity Interval Training (MF-HIIT)

Experimental

干预措施: MF-HIIT (Behavioral)

12-Week High-Intensity Interval Training (HIIT-only)

Active Comparator

干预措施: HIIT-only (Behavioral)

12-Week Mindfulness (MF-only)

Active Comparator

干预措施: MF-only (Behavioral)

12-Week Sedentary Activities

Placebo Comparator

干预措施: Sedentary activity (Behavioral)

结局指标

主要结局

Updating speed

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.

Shifting speed

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Shifting speed will be assessed by the response time (ms) during a child-friendly switching task.

Inhibition accuracy

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.

Inhibition speed

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.

Updating accuracy

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.

Shifting accuracy

时间窗: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Shifting accuracy will be assessed by the response accuracy (percent) during a child-friendly switching task.

次要结局

  • Body composition(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Core body muscle endurance(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Aerobic capacity(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Dispositional mindfulness(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Flexibility(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Upper body muscle endurance(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)

研究者

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

Shih-Chun Kao

Assistant Professor

Purdue University

研究点 (2)

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