The HIIT Cognition Study

The Effects of High Intensity Exercise in Teens on Cognition

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.

Study Overview

• Status: Completed
• Conditions: High Intensity Interval Training; Overweight and Obesity; Cognition; Metabolic Disease
• Intervention / Treatment: Behavioral: HIIT Exercise Intervention; Behavioral: Stretching Intervention

Detailed Description

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).

Those randomized to the HIIT group will receive the intervention 3 times/week and will be given a pre-assembled stationary bicycle to use to complete each exercise session, an iPad to Zoom with the exercise trainers, and a Fitbit to assess real-time heart rate. Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.

Those randomized to the control group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred.

Study arms: Study participants will be randomly assigned to receive either the HIIT intervention (HIIT group) or receive the stretching intervention (control group).

Endpoints/Outcomes: The primary cognitive and mental health endpoints are: executive function, episodic memory, working memory, affect, mood, anxiety, stress, self-efficacy for PA, and PA enjoyment. The primary cardiometabolic endpoints are: glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance), IL-6, IL-1, TNF-a, and VEGF.

Statistical analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90032
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT Exercise Intervention; At home (N=12): Participants will complete an exercise session 3 times a week for 14 weeks. Each participant will receive a pre-assembled stationary bicycle to use to complete each session, an iPad to receive the intervention virtually from exercise trainers through Zoom, and a Fitbit to assess real-time heart rate.	Behavioral: HIIT Exercise Intervention; Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.; Other Names: Exercise group
Placebo Comparator: Stretching Intervention; At home (N=12): Participants will complete a stretching protocol 3 times a week for 14 weeks. Participants will be asked to complete weekly records of flexibility compliance.	Behavioral: Stretching Intervention; This group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred. To increase compliance and aid in the standardization of the home-based stretching, participants will be provided a booklet of the flexibility exercises. Participants will be shown how to use the booklet and instructed in the stretching exercises by an exercise trainer prior to the intervention.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of intervention feasibility	percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions	14 weeks
Measures of intervention efficacy	percent of sessions where youth achieve their target heart rate	14 weeks
Intervention Feasibility Measure	4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility	14 weeks
Intervention Acceptability Measure	4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability	14 weeks
Intervention Appropriateness Measure	4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness	14 weeks
Cognitive function measures	executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores	14 weeks
Positive and Negative Affect Scale for Children	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	14 weeks
Profile of Mood States for Adolescents	24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome	14 weeks
State-Trait Anxiety Inventory for Children	20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety	14 weeks
Perceived Stress Scale	10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items	14 weeks
Stress in Children Scale	21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items	14 weeks
Self-Efficacy for Physical Activity Scale	5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome	14 weeks
Physical Activity Enjoyment Scale	18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items	14 weeks
Glucose Sensitivity	glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)	14 weeks
Markers of inflammation	interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL	14 weeks
Vascular Endothelial-Derived Growth	vascular endothelial growth factor (VEGF) in pg/mL	14 weeks
Cardiorespiratory Fitness	maximal oxygen consumption (VO2max)	14 weeks
Blood Pressure	systolic and diastolic blood pressure	14 weeks
Body proportion	waist-to-height ratio	14 weeks
Body composition	percent body fat	14 weeks

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Mental Health; High Intensity Interval Training; Pediatric Obesity; Metabolic Disturbances
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Metabolic Diseases
• Other Study ID Numbers: HS-21-00149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not intend to share IPD with other researchers outside of our study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No