- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01935323
High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents (HIIT-MAX)
January 8, 2016 updated by: David Allison, Phd, University of Alabama at Birmingham
High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- UAB Physiology Lab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 22 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: High Intensity Interval Training
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.
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ACTIVE_COMPARATOR: Moderate Intensity Training
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Body Composition as measured by DXA
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body Weight
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Blood Pressure
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Body Mass Index
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Peak uptake of volume of oxygen
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Wingate Cycle test
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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LDL Cholesterol
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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HDL Cholesterol
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Triglycerides
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Glucose
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
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Insulin
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Ghrelin
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Leptin
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
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Adiponectin
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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PYY
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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IL-6
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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TNF-alpha
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Total antioxidant capacity
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Protein Carbonyls
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Free living energy expenditure as measured by accelerometer
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
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Appetite/satiety measures
Time Frame: baseline & 6 weeks
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composite score
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baseline & 6 weeks
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Quality & satisfaction with life
Time Frame: baseline & 6 weeks
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composite score
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baseline & 6 weeks
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Rate of perceived exertion during exercise via Borg Scale
Time Frame: baseline and 6 weeks
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baseline and 6 weeks
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24-hour dietary recall
Time Frame: pre-baseline, baseline, 6 weeks
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pre-baseline, baseline, 6 weeks
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Self Motivation Inventory
Time Frame: baseline and 6 weeks
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baseline and 6 weeks
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Profile of Mood States
Time Frame: baseline & 6 weeks
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baseline & 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
August 30, 2013
First Posted (ESTIMATE)
September 5, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F121101004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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