CASH- Children Active to Stay Healthy (CASH)

April 23, 2015 updated by: Ihuoma Eneli, Nationwide Children's Hospital

Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity

The purpose of this study is to examine the effects of high intensity interval exercise (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our working hypothesis is that, compared with obese children prescribed moderate exercise, obese children prescribed HIIE will demonstrate greater improvements in endothelial function and inflammatory markers following a 6-week exercise intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity, even in children, is generally accompanied by a state of chronic inflammation. To combat childhood obesity, clinicians and scientists recommend lifestyle interventions that include increased physical activity and exercise in an attempt to promote weight loss and, consequently, decrease comorbidities associated with excess adiposity. More importantly, it appears that the influence of regular exercise may offer children with obesity a multitude of health benefits, independent of weight loss. However, the intensity of exercise required to elicit significant health benefits is still unclear. Therefore, the aim of the present project is to study the influence of high intensity interval exercise (HIIE) on the existing inflammatory state found in obesity. Specifically, the proposed project will examine endothelial function and markers of inflammation, such as TNFa, IL-6, hsCRP, and adiponectin, in children with obesity before and after an exercise intervention. The data will then be used to determine if changes in these values differ in magnitude based on the intensity of exercise. Children with obesity will be randomized into either moderate exercise or HIIE groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform ten, 2-minute bouts at 90%-95% of maximal heart rate. Outcome measures of body composition, aerobic capacity, blood lipids, glucose metabolism, endothelial function, and inflammation will be measured pre- and post-intervention. Results may help in establishing exercise protocols not only for children with obesity, but also other inflammatory diseases such as diabetes, cancer, and arthritis.

Study Type

Interventional

Enrollment (Actual)

43

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

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

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 13-17 years old
  • obesity (defined as as BMI≥ 95th percentile for age and sex as defined by the Centers for Disease Control

Exclusion Criteria:

  • active participation in ≥30 minutes of vigorous exercise more than 2 days per week
  • participation in an organized combined diet/exercise weight loss intervention
  • acute inflammatory disease or febrile illness
  • recent trauma or injury
  • asthma requiring steroid use or that has resulted in hospitalization within 3 months prior to enrollment
  • chronic disease known to affect inflammation (e.g. lupus)
  • any renal, heart, or liver disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate exercise
The subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The moderate exercise group will begin with a five-minute warm-up, cycling at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the moderate group will cycle for 30 minutes at 65-70% of maximal heart rate. The subject will then complete a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors.
Other: Moderate exercise
Active Comparator: High Intensity Interval Exercise (HIIE)
The subject will participate in a 6-week exercise intervention, 3 days per week on a cycle ergometer. The subjects in the HIIE group will begin with a five-minute warm-up at 50-55% of the subject's maximal heart rate as determined by the initial fitness assessment. Following the warm-up, the HIIE group will perform 10, two-minute exercise bouts at 90-95% of maximal heart rate, with one minute of active recovery at 55% of maximal heart rate between each interval for a total of 30 minutes. They will complete the test with a 5-minute cool-down at 50-55% of maximal heart rate. Heart rate will be measured via individual heart rate monitors.
Other: High Intensity Interval Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation and endothelial function measured via forearm vascular resistance (FVR) and blood markers including tumor necrosis factor alpha (TNF-a), interleukin-6 (IL-6), adiponectin, high sensitivity C-reactive protein (hsCRP), and endothelin 1.
Time Frame: Within one month pre and one month post-intervention
The primary outcomes are the percent change in FVR and in inflammatory markers (hsCRP, IL-6, TNF-α, and adiponectin) from pre- to post-intervention in both groups.
Within one month pre and one month post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent difference in inflammation and endothelial function between moderate and high intensity interval exercise (HIIE) groups.
Time Frame: Within one month pre- and no more than one month post-intervention
Within one month pre- and no more than one month post-intervention

Collaborators and Investigators

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

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Andrea Bonny, MD, Nationwide Children's Hospital
  • Principal Investigator: Robert Hoffman, MD, Nationwide Children's Hospital
  • Principal Investigator: Steven T Devor, Ph.D., Ohio State University

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.

General Publications

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

September 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-00197

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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