NCT01935323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

June 20, 2013

Last Update Submit

January 8, 2016

Conditions

Keywords

high intensity interval trainingaerobic exerciseinsulin sensitivityobesitycardiovascular fitness

Outcome Measures

Primary Outcomes (1)

  • Body Composition as measured by DXA

    Baseline and 6 weeks

Secondary Outcomes (25)

  • Body Weight

    Baseline and 6 weeks

  • Blood Pressure

    Baseline and 6 weeks

  • Body Mass Index

    Baseline and 6 weeks

  • Peak uptake of volume of oxygen

    Baseline and 6 weeks

  • Wingate Cycle test

    Baseline and 6 weeks

  • +20 more secondary outcomes

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

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.

Other: High Intensity Interval Training

Moderate Intensity Training

ACTIVE COMPARATOR

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.

Other: Moderate Intensity Training

Interventions

High Intensity Interval Training
Moderate Intensity Training

Eligibility Criteria

Age17 Years - 22 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Physiology Lab

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 26489022BACKGROUND

Related Links

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2013

First Posted

September 5, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations