CASH- Children Active to Stay Healthy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Ihuoma Eneli, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01821313
First received: March 27, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Childhood Obesity
Inflammation
Other: Moderate exercise
Other: High Intensity Interval Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: September 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821313

Contacts
Contact: Brooke E Starkoff, M.Ed. 216 408-2238 brooke.starkoff@osu.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Brooke E Starkoff, M.Ed.    216-408-2238    brooke.starkoff@osu.edu   
Sub-Investigator: Brooke E. Starkoff, M.Ed.         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Ihuoma Eneli, MD Nationwide Children's Hospital
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
  More Information

Publications:

Responsible Party: Ihuoma Eneli, Medical director/ Associate professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01821313     History of Changes
Other Study ID Numbers: IRB12-00197
Study First Received: March 27, 2013
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Childhood obesity
Inflammation
Endothelial function
Exercise

Additional relevant MeSH terms:
Obesity
Inflammation
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014