The HIIT Cognition Study

Overweight and Obesity Clinical Trial

Official title:

The Effects of High Intensity Exercise in Teens on Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137990
• Other study ID #: HS-21-00149
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• High Intensity Interval Training
• Metabolic Disease
• Metabolic Diseases
• Overweight
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measures of intervention efficacy	percent of sessions where youth achieve their target heart rate	14 weeks
Primary	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
Primary	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
Primary	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
Primary	Cognitive function measures	executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores	14 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Glucose Sensitivity	glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)	14 weeks
Primary	Markers of inflammation	interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL	14 weeks
Primary	Vascular Endothelial-Derived Growth	vascular endothelial growth factor (VEGF) in pg/mL	14 weeks
Primary	Cardiorespiratory Fitness	maximal oxygen consumption (VO2max)	14 weeks
Primary	Blood Pressure	systolic and diastolic blood pressure	14 weeks
Primary	Body proportion	waist-to-height ratio	14 weeks
Primary	Body composition	percent body fat	14 weeks