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MetabolismHIIT-MAXNCT01935323

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

A study testing High Intensity Interval Training and Moderate Intensity Training in people with Metabolism and Physical Fitness, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 22 years, men onlyHealthy volunteers can take part
Conditions the study is for
Metabolism, Physical Fitness
What is being tested?
High Intensity Interval Training and Moderate Intensity Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 22 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB Physiology Lab

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: 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.

Being tested
High Intensity Interval Training, Moderate Intensity Training
Keywords
high intensity interval training, aerobic exercise, insulin sensitivity, obesity, cardiovascular fitness
Medical subject headings
Insulin Resistance, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingOther

  • Moderate Intensity TrainingOther

Study groups in NCT01935323
Study groupRoleWhat they receive
High Intensity Interval TrainingExperimentalParticipants 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.
Receives: Other: High Intensity Interval Training
Moderate Intensity TrainingActive comparatorParticipants 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.
Receives: Other: Moderate Intensity Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Composition as measured by DXA

    Measured: Baseline and 6 weeks

Secondary outcomes (25)

  1. Body Weight

    Measured: Baseline and 6 weeks

  2. Blood Pressure

    Measured: Baseline and 6 weeks

  3. Body Mass Index

    Measured: Baseline and 6 weeks

  4. Peak uptake of volume of oxygen

    Measured: Baseline and 6 weeks

  5. Wingate Cycle test

    Measured: Baseline and 6 weeks

  6. LDL Cholesterol

    Measured: Baseline and 6 weeks

  7. HDL Cholesterol

    Measured: Baseline and 6 weeks

  8. Triglycerides

    Measured: Baseline and 6 weeks

  9. Glucose

    Measured: Baseline and 6 weeks

  10. Insulin

    Measured: Baseline and 6 weeks

  11. Ghrelin

    Measured: Baseline and 6 weeks

  12. Leptin

    Measured: Baseline and 6 weeks

  13. Adiponectin

    Measured: Baseline and 6 weeks

  14. PYY

    Measured: Baseline and 6 weeks

  15. IL-6

    Measured: Baseline and 6 weeks

  16. TNF-alpha

    Measured: Baseline and 6 weeks

  17. Total antioxidant capacity

    Measured: Baseline and 6 weeks

  18. 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.

    Measured: Baseline and 6 weeks

  19. Free living energy expenditure as measured by accelerometer

    Measured: Baseline and 6 weeks

  20. Appetite/satiety measures

    composite score

    Measured: baseline & 6 weeks

  21. Quality & satisfaction with life

    composite score

    Measured: baseline & 6 weeks

  22. Rate of perceived exertion during exercise via Borg Scale

    Measured: baseline and 6 weeks

  23. 24-hour dietary recall

    Measured: pre-baseline, baseline, 6 weeks

  24. Self Motivation Inventory

    Measured: baseline and 6 weeks

  25. Profile of Mood States

    Measured: baseline & 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01935323
Sponsor's protocol ID
F121101004
Acronym
HIIT-MAX
Status last verified
Jan 2016
First submitted
20 Jun 2013
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26489022

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training and Moderate Intensity Training in people with Metabolism and Physical Fitness, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Composition as measured by DXA (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01935323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.

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