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High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents (HIIT-MAX)

Primary Purpose

Metabolism, Physical Fitness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Intensity Training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolism focused on measuring high intensity interval training, aerobic exercise, insulin sensitivity, obesity, cardiovascular fitness

Eligibility Criteria

17 Years - 22 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 17-22
  • Men
  • BMI (25.0 - 35.0 kg/m2)
  • Interested in improving health and fitness

Exclusion Criteria:

  • Weight loss or gain of >10% of body weight in the past 6 months for any reason.
  • Currently taking medication that suppresses or stimulates appetite.
  • History of prior surgical procedure for weight control or liposuction.
  • Current smoker.

Any major disease, including:

  • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
  • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
  • Diagnosed heart conditions.
  • Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Asthma.

  • Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.

    • Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
    • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
    • Any active use of illegal or illicit drugs.
    • Excessive alcohol intake defined as an average consumption of 3 or more alcohol containing beverages daily.
    • Unwilling to limit alcohol intake to ≤2 drink per day (one drink = 4 oz. wine, 12 oz. beer, or ½ shot of liquor).
    • Current exerciser (>30 min organized exercise per week).
    • Indication of unsuitability of current health for exercise protocol (PARQ).
    • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Sites / Locations

  • UAB Physiology Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training

Moderate Intensity Training

Arm Description

Participants will perform the HIIT protocol on an electronically-braked cycle ergometer (Quinton Excalibur, Quinton Instrument Company, Bothell, WA). Participants will perform a 20-minute protocol, consisting of four minutes of cycling at 15% of maximum anaerobic power (Max-AP) followed by 30 seconds at 85% of Max-AP. These workloads will be based upon pre-trial Wingate tests. This cycle was repeated four times within each protocol, ending with two minutes at 15% of Max-AP. This will be performed 3d/wk for 6wks, with at least 24 hrs between each session.

Participants will perform 45-60 min (graduated over time to 60) of continuous cycling at 65% of VO¬2peak on a Monark cycle ergometer. Workload will be based upon pre-trial VO¬2peak testing. MIT exercise will be performed 5d/wk for 6wks.

Outcomes

Primary Outcome Measures

Body Composition as measured by DXA

Secondary Outcome Measures

Body Weight
Blood Pressure
Body Mass Index
Peak uptake of volume of oxygen
Wingate Cycle test
LDL Cholesterol
HDL Cholesterol
Triglycerides
Glucose
Insulin
Ghrelin
Leptin
Adiponectin
PYY
IL-6
TNF-alpha
Total antioxidant capacity
Protein Carbonyls
ELISA assay purchased from NW LifeSciences. Prior to analysis, all serum samples were assayed for protein concentration based on the methods of Bradford and adjusted to 4 mg・mL-1 protein using a phosphate buffer. Protein carbonyls, a measure of protein oxidation, were analyzed in duplicate in 50 μl of sera using a commercially available ELISA kit (NWK-PCK01).The intra- and interassay coefficients of variation were 2.7 % and 5%. The lower detection limit of the assay was 0.1 nmol/mg.
Free living energy expenditure as measured by accelerometer
Appetite/satiety measures
composite score
Quality & satisfaction with life
composite score
Rate of perceived exertion during exercise via Borg Scale
24-hour dietary recall
Self Motivation Inventory
Profile of Mood States

Full Information

First Posted
June 20, 2013
Last Updated
January 8, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
The Coca-Cola Company
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1. Study Identification

Unique Protocol Identification Number
NCT01935323
Brief Title
High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents
Acronym
HIIT-MAX
Official Title
High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
The Coca-Cola Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
6-week, single site, two parallel arm, randomized, controlled trial comparing the effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce similar metabolic and cardiovascular adaptations typically associated with MIT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism, Physical Fitness
Keywords
high intensity interval training, aerobic exercise, insulin sensitivity, obesity, cardiovascular fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
Participants will perform the HIIT protocol on an electronically-braked cycle ergometer (Quinton Excalibur, Quinton Instrument Company, Bothell, WA). Participants will perform a 20-minute protocol, consisting of four minutes of cycling at 15% of maximum anaerobic power (Max-AP) followed by 30 seconds at 85% of Max-AP. These workloads will be based upon pre-trial Wingate tests. This cycle was repeated four times within each protocol, ending with two minutes at 15% of Max-AP. This will be performed 3d/wk for 6wks, with at least 24 hrs between each session.
Arm Title
Moderate Intensity Training
Arm Type
Active Comparator
Arm Description
Participants will perform 45-60 min (graduated over time to 60) of continuous cycling at 65% of VO¬2peak on a Monark cycle ergometer. Workload will be based upon pre-trial VO¬2peak testing. MIT exercise will be performed 5d/wk for 6wks.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Training
Primary Outcome Measure Information:
Title
Body Composition as measured by DXA
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Body Weight
Time Frame
Baseline and 6 weeks
Title
Blood Pressure
Time Frame
Baseline and 6 weeks
Title
Body Mass Index
Time Frame
Baseline and 6 weeks
Title
Peak uptake of volume of oxygen
Time Frame
Baseline and 6 weeks
Title
Wingate Cycle test
Time Frame
Baseline and 6 weeks
Title
LDL Cholesterol
Time Frame
Baseline and 6 weeks
Title
HDL Cholesterol
Time Frame
Baseline and 6 weeks
Title
Triglycerides
Time Frame
Baseline and 6 weeks
Title
Glucose
Time Frame
Baseline and 6 weeks
Title
Insulin
Time Frame
Baseline and 6 weeks
Title
Ghrelin
Time Frame
Baseline and 6 weeks
Title
Leptin
Time Frame
Baseline and 6 weeks
Title
Adiponectin
Time Frame
Baseline and 6 weeks
Title
PYY
Time Frame
Baseline and 6 weeks
Title
IL-6
Time Frame
Baseline and 6 weeks
Title
TNF-alpha
Time Frame
Baseline and 6 weeks
Title
Total antioxidant capacity
Time Frame
Baseline and 6 weeks
Title
Protein Carbonyls
Description
ELISA assay purchased from NW LifeSciences. Prior to analysis, all serum samples were assayed for protein concentration based on the methods of Bradford and adjusted to 4 mg・mL-1 protein using a phosphate buffer. Protein carbonyls, a measure of protein oxidation, were analyzed in duplicate in 50 μl of sera using a commercially available ELISA kit (NWK-PCK01).The intra- and interassay coefficients of variation were 2.7 % and 5%. The lower detection limit of the assay was 0.1 nmol/mg.
Time Frame
Baseline and 6 weeks
Title
Free living energy expenditure as measured by accelerometer
Time Frame
Baseline and 6 weeks
Title
Appetite/satiety measures
Description
composite score
Time Frame
baseline & 6 weeks
Title
Quality & satisfaction with life
Description
composite score
Time Frame
baseline & 6 weeks
Title
Rate of perceived exertion during exercise via Borg Scale
Time Frame
baseline and 6 weeks
Title
24-hour dietary recall
Time Frame
pre-baseline, baseline, 6 weeks
Title
Self Motivation Inventory
Time Frame
baseline and 6 weeks
Title
Profile of Mood States
Time Frame
baseline & 6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 17-22 Men BMI (25.0 - 35.0 kg/m2) Interested in improving health and fitness Exclusion Criteria: Weight loss or gain of >10% of body weight in the past 6 months for any reason. Currently taking medication that suppresses or stimulates appetite. History of prior surgical procedure for weight control or liposuction. Current smoker. Any major disease, including: Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer). Active or chronic infections, including self-reported HIV positivity and active tuberculosis. Diagnosed heart conditions. Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment. Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy). Asthma. Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications. Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes. Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months). Any active use of illegal or illicit drugs. Excessive alcohol intake defined as an average consumption of 3 or more alcohol containing beverages daily. Unwilling to limit alcohol intake to ≤2 drink per day (one drink = 4 oz. wine, 12 oz. beer, or ½ shot of liquor). Current exerciser (>30 min organized exercise per week). Indication of unsuitability of current health for exercise protocol (PARQ). Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Facility Information:
Facility Name
UAB Physiology Lab
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26489022
Citation
Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.
Results Reference
background
Links:
URL
http://www.norc.uab.edu
Description
UAB Nutrition Obesity Research Center

Learn more about this trial

High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents

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