Effects of High-Intensity Interval Training Exercise in A... | NCT04342390

ID	Type	Description	Link
P20GM109096	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of General Medical Sciences (NIGMS)	NIH

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise Group	Experimental	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT).	Other: High-Intensity Interval Training (HIIT)
Control Group	No Intervention	Study participants in this group will not undergo HIIT exercise training during this study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-Intensity Interval Training (HIIT)	Other	The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intrahepatic Triglyceride (IHTG)	Intrahepatic triglyceride (IHTG) percent (%) will be measured via Magnetic Resonance Imaging (MRI). IHTG percent can theoretically range between 0 and 100. By definition, an individual has Non-Alcoholic Fatty Liver Disease (NAFLD) when the IHTG percent is at or above 5 percent.	4 weeks
Cardiovascular Fitness	Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight per minute in kilograms of lean body mass (mL/min/kg per LBM). There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.	4 weeks
HOMA-IR	The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the fasting glucose and insulin levels. Higher HOMA-IR values indicate greater insulin resistance. HOMA-IR is calculated as "fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5". HOMA-IR has an arbitrary unit. Higher numbers suggest worse outcomes.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Alanine Aminotransferase	Serum alanine aminotransferase (ALT) level will be measured. ALT level is reported in international unit/liter or IU/L. Higher ALT levels suggest presence of hepatocellular damage.	4 weeks
FibroScan - Controlled Attenuated Parameter

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Initial Enrollment

Ages 13-18 years (inclusive) for both sexes
Any ethnic/racial background
English speaking competence
Teenagers ages 13-15 weighing more than 145 pounds OR teenagers ages 16-18 weighing more than 170 pounds
Low risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
Late stages of puberty (i.e., Tanner stage IV or V) based on Tanner Staging.

Inclusion Criteria: Control or Exercise Group

Presence of Non-Alcoholic Fatty Liver Disease (NAFLD) as determined by FibroScan Controlled Attenuated Parameter (CAP) score
Confirmed lack of diabetes as determined by Oral Glucose Tolerance Test (OGTT)
Confirmed eligibility per medical history

Exclusion criteria:

Pre-pubertal or early stages of puberty
Pregnancy
Confirmed lack of NAFLD in the past 6 months via biopsy or MRI
Presence of an implantable medical device or metal objects in the body (a contraindication for FibroScan and/or MRI)
High-risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
Unable to cooperate with study procedures and tests including genetic or physical conditions impacting mobility over the past year
Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, type 2 diabetes, neurologic (e.g., epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (Cushing's, growth hormone deficiency), hepatic (other than NAFLD), autoimmune, cardiac and renal disorders
Current history of poorly-controlled asthma.
Taking any of the following medications that can affect study outcome at the time of enrollment: insulin, metformin, or any other anti-diabetics, antipsychotics, oral steroids, and anabolic drugs (growth hormone replacement therapy, testosterone, and oxandrolone).
Adolescents who have a history of claustrophobia.
Adolescents who need sedation in order to complete MRI.
Adolescents determined ineligible by the study investigator or delegated staff.

Name	Affiliation	Role
Emir Tas, MD	Arkansas Children's Hospital Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States
Arkansas Children's Pediatric Clinical Research Unit

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 16, 2021

Arm/Group Information

ID	Title	Description
BG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
BG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00034 BG0016 BG00240

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00015.2± 1.5 BG00115.4± 1.0 BG00215.2± 1.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00013 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Intrahepatic Triglyceride (IHTG)

Intrahepatic triglyceride (IHTG) percent (%) will be measured via Magnetic Resonance Imaging (MRI). IHTG percent can theoretically range between 0 and 100. By definition, an individual has Non-Alcoholic Fatty Liver Disease (NAFLD) when the IHTG percent is at or above 5 percent.

Posted

Mean

Standard Deviation

percentage of IHTG

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants	OG00031 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0005.26± 3.01 OG0018.97± 6.61

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.363														Superiority

Primary

Cardiovascular Fitness

Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight per minute in kilograms of lean body mass (mL/min/kg per LBM). There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.

Posted

Mean

Standard Error

mL/min/kg of Lean Body Mass

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants

Primary

HOMA-IR

The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the fasting glucose and insulin levels. Higher HOMA-IR values indicate greater insulin resistance. HOMA-IR is calculated as "fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5". HOMA-IR has an arbitrary unit. Higher numbers suggest worse outcomes.

Posted

Mean

Standard Deviation

arbitrary unit

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants

Secondary

Alanine Aminotransferase

Serum alanine aminotransferase (ALT) level will be measured. ALT level is reported in international unit/liter or IU/L. Higher ALT levels suggest presence of hepatocellular damage.

Posted

Mean

Standard Error

international unit/liter

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants	OG000

Secondary

FibroScan - Controlled Attenuated Parameter

Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/meter (dB/m) and ranges between 100-400. A score of 241 dB/m or greater is consistent with non-alcoholic fatty liver disease.

Posted

Mean

Standard Deviation

decibel/meter

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants

Secondary

FibroScan - Transient Elastogram

Transient Elastogram (TE) score will be measured using FibroScan. TE score is reported in kilopascals (kPa) and ranges between 0-75. A score of 8.5 kPa or greater is consistent with fibrotic liver disease.

Posted

Mean

Standard Deviation

kPa

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants	OG000

Secondary

Body Composition - Total Body Fat

Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat is not established; however, larger total body fat percentage (percentage of total body weight) is linked to higher intrahepatic triglyceride content and insulin resistant state.

Posted

Mean

Standard Deviation

percentage of total body weight

4 weeks

ID	Title	Description
OG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
OG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Exercise Group	Study participants in this group will be asked to complete 4 weeks of high-intensity interval training (HIIT). High-Intensity Interval Training (HIIT): The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.	0	34	0	34	1	34
EG001	Control Group	Study participants in this group will not undergo HIIT exercise training during this study.	0	6	0	6	0	6

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D007333	Insulin Resistance
D063766	Pediatric Obesity
D005234	Fatty Liver

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena