Trial Outcomes & Findings for Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis (NCT NCT04342390)
NCT ID: NCT04342390
Last Updated: 2024-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
6
|
|
Overall Study
COMPLETED
|
31
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Baseline characteristics by cohort
| Measure |
Exercise Group
n=34 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksIntrahepatic 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Intrahepatic Triglyceride (IHTG)
|
5.26 percentage of IHTG
Standard Deviation 3.01
|
8.97 percentage of IHTG
Standard Deviation 6.61
|
PRIMARY outcome
Timeframe: 4 weeksCardiovascular 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Cardiovascular Fitness
|
40.8 mL/min/kg of Lean Body Mass
Standard Error 7.3
|
43.2 mL/min/kg of Lean Body Mass
Standard Error 7.2
|
PRIMARY outcome
Timeframe: 4 weeksThe 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
HOMA-IR
|
8.69 arbitrary unit
Standard Deviation 5.5
|
6.4 arbitrary unit
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 4 weeksSerum 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Alanine Aminotransferase
|
20.1 international unit/liter
Standard Error 17.6
|
29.7 international unit/liter
Standard Error 17.6
|
SECONDARY outcome
Timeframe: 4 weeksControlled 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
FibroScan - Controlled Attenuated Parameter
|
279 decibel/meter
Standard Deviation 35
|
280 decibel/meter
Standard Deviation 35
|
SECONDARY outcome
Timeframe: 4 weeksTransient 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
FibroScan - Transient Elastogram
|
5 kPa
Standard Deviation 1
|
5 kPa
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 4 weeksBody 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.
Outcome measures
| Measure |
Exercise Group
n=31 Participants
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.
|
Control Group
n=6 Participants
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Body Composition - Total Body Fat
|
45.35 percentage of total body weight
Standard Deviation 6.18
|
44.05 percentage of total body weight
Standard Deviation 6.18
|
Adverse Events
Exercise Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise Group
n=34 participants at risk
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.
|
Control Group
n=6 participants at risk
Study participants in this group will not undergo HIIT exercise training during this study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle sprain
|
2.9%
1/34 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place