High-intensity Interval Training in Overweight/Obese

November 29, 2016 updated by: University of North Carolina, Chapel Hill

Impact of Varying High-intensity Interval Protocols on Cardiometabolic Risk Factors in Overweight/Obese

Purpose: The purpose of this study would be to evaluate the effects of interval training on cardiovascular health, lipid profile and body composition in overweight and obese men and women.

A secondary purpose will be to compare lab based measurements of body composition [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy (BIS) and ultrasound (US)]

Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly assigned to a high-intensity short interval group (SIT), high-intensity long interval group (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants assigned to either training group will undergo 3 weeks of interval training, 3 days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power output).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written and dated informed consent to participate in the study.
  • willing and able to comply with the protocol.
  • good health as determined by a health and exercise status questionnaire
  • normal electrocardiogram (ECG), and physical.
  • body mass index of 25-45 kg/m 2.
  • has been cleared for participation by a physician (either study or personal).

Exclusion Criteria:

  • participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
  • has lost ten or more pounds during the previous three months and maintained the weight loss.
  • significant history or current presence of untreated high blood pressure (BP) [systolic BP> 140 mmHg and/or diastolic BP> 90 mmHg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
  • has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
  • are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No exercise
Experimental: High-intensity interval -2min
5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.
Behavioral: Interval training
Experimental: High-intensity interval -1min
10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods
Behavioral: Interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiorespiratory Fitness (VO2peak)
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Composition
Time Frame: 3 weeks
3 weeks
Blood Lipids
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

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

August 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1026

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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