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临床试验/NCT05137990
NCT05137990已完成不适用

The Effects of High Intensity Exercise in Teens on Cognition

University of Southern California2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Profile of Mood States for Adolescents

研究概览

简要总结

This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad or b) 14 weeks of a stretching intervention (control group). Each participant will undergo an in-lab pre- and post-test visit, where they will complete a fasting blood draw, a fitness test, and various cognitive and mental health measures.

详细描述

Rationale: Existing literature supports the premise that physical activity (PA) has beneficial effects on cognitive function in youth, but prior studies have limitations, such as cross-sectional designs with limited insights on the intensity or duration of PA or the biological underpinnings linking physical activity and mental health and cognitive function in adolescents. A limited number of studies (and none in the U.S.) have evaluated the effects of HIIT on cognitive processes in youth, particularly in youth with overweight/obesity whose age-related declines in PA puts them at increased risk for poor outcomes. This study is particularly timely during the current COVID-19 related public health crisis because our HIIT exercise intervention is time efficient, delivered remotely, and completed using space-efficient equipment in the home.

Intervention: Participants (youth ages 12-16 years with overweight/obesity) will be randomly assigned to complete a) 14 weeks of a home-based virtual, interactive HIIT intervention or b) 14 weeks of a stretching intervention (control group).

Objectives/Purpose: The overall goal is to improve cognitive and cardiometabolic outcomes in youth with overweight/obesity by implementing an at-home HIIT intervention. The aims of this study are: 1) to determine the feasibility, acceptability, and efficacy of HIIT in adolescents with overweight/obesity, 2) to examine the effectiveness of HIIT on cognitive and mental health outcomes, and 3) to examine the effectiveness of HIIT on cardiometabolic health.

Study Population: This study will consist of youth ages 12-16 years with overweight/obesity (BMI >=85th percentile) who do not meet current PA guidelines.

Study Methodology: This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad (HIIT group) or b) 14 weeks of a stretching intervention (control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Typically developing youth.
  • Overweight/obese (BMI >= 85th percentile)
  • Does not meet current PA guidelines
  • Able and willing to complete HIIT exercise intervention.
  • Space for a stationary bike in the residence.

排除标准

  • Diagnoses of neurodevelopment or psychiatric disorders.
  • Diabetes, cardiovascular, pulmonary, or other significant medical problems.
  • Taking medications know to alter metabolism.
  • Allergy to metals.
  • Inability to participate in HIIT-based exercise or active involvement in sports/exercise programs.

结局指标

主要结局

Profile of Mood States for Adolescents

时间窗: 14 weeks

24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome

Self-Efficacy for Physical Activity Scale

时间窗: 14 weeks

5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome

Physical Activity Enjoyment Scale

时间窗: 14 weeks

18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items

Blood Pressure

时间窗: 14 weeks

systolic and diastolic blood pressure

Measures of intervention feasibility

时间窗: 14 weeks

percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions

Measures of intervention efficacy

时间窗: 14 weeks

percent of sessions where youth achieve their target heart rate

Intervention Feasibility Measure

时间窗: 14 weeks

4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility

Intervention Appropriateness Measure

时间窗: 14 weeks

4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness

Cognitive function measures

时间窗: 14 weeks

executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores

Glucose Sensitivity

时间窗: 14 weeks

glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)

Intervention Acceptability Measure

时间窗: 14 weeks

4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability

Vascular Endothelial-Derived Growth

时间窗: 14 weeks

vascular endothelial growth factor (VEGF) in pg/mL

Positive and Negative Affect Scale for Children

时间窗: 14 weeks

10-item positive and negative affect scale with scores for each ranging from 0 to 5; higher scores indicate a worse outcome for negative affect and better outcome for positive affect

State-Trait Anxiety Inventory for Children

时间窗: 14 weeks

20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety

Perceived Stress Scale

时间窗: 14 weeks

10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items

Stress in Children Scale

时间窗: 14 weeks

21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items

Markers of inflammation

时间窗: 14 weeks

interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL

Cardiorespiratory Fitness

时间窗: 14 weeks

maximal oxygen consumption (VO2max)

Body proportion

时间窗: 14 weeks

waist-to-height ratio

Body composition

时间窗: 14 weeks

percent body fat

次要结局

未报告次要终点

研究者

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

Britni Ryan Belcher, PhD, MPH

Assistant Professor

University of Southern California

研究点 (2)

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