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Trial record 60 of 232 for:    EDN1

CASH- Children Active to Stay Healthy (CASH)

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ClinicalTrials.gov Identifier: NCT01821313
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Ihuoma Eneli, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE March 27, 2013
First Posted Date  ICMJE April 1, 2013
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01821313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CASH- Children Active to Stay Healthy
Official Title  ICMJE Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Childhood Obesity
  • Inflammation
Intervention  ICMJE
  • Other: Moderate exercise
  • Other: High Intensity Interval Exercise
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: High Intensity Interval Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2015)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2013)
54
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821313
Other Study ID Numbers  ICMJE IRB12-00197
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ihuoma Eneli, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Nationwide Children's Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP