The HIIT Cognition Study

Sponsor

University of Southern California (Other)

Overall Status

Recruiting

CT.gov ID

NCT05137990

Collaborator

Dana-Farber Cancer Institute (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
High Intensity Interval Training Overweight and Obesity Metabolic Disease Cognition	Behavioral: HIIT Exercise Intervention Behavioral: Stretching Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized to complete one of two conditions: 1) 14 weeks of a home-based virtual HIIT exercise intervention or 2) 14 weeks of a stretching intervention (control group).Participants will be randomized to complete one of two conditions: 1) 14 weeks of a home-based virtual HIIT exercise intervention or 2) 14 weeks of a stretching intervention (control group).

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Effects of High Intensity Exercise in Teens on Cognition

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Measures of intervention feasibility [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 [14 weeks]
percent of sessions where youth achieve their target heart rate
Intervention Feasibility Measure [14 weeks]
4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility
Intervention Acceptability Measure [14 weeks]
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability
Intervention Appropriateness Measure [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 [14 weeks]
executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores
Positive and Negative Affect Scale for Children [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
Profile of Mood States for Adolescents [14 weeks]
24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome
State-Trait Anxiety Inventory for Children [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 [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 [14 weeks]
21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Self-Efficacy for Physical Activity Scale [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 [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
Glucose Sensitivity [14 weeks]
glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)
Markers of inflammation [14 weeks]
interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL
Vascular Endothelial-Derived Growth [14 weeks]
vascular endothelial growth factor (VEGF) in pg/mL
Cardiorespiratory Fitness [14 weeks]
maximal oxygen consumption (VO2max)
Blood Pressure [14 weeks]
systolic and diastolic blood pressure
Body proportion [14 weeks]
waist-to-height ratio
Body composition [14 weeks]
percent body fat

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Pregnancy.