CASH- Children Active to Stay Healthy (CASH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01821313|
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity Inflammation||Other: Moderate exercise Other: High Intensity Interval Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of High Intensity Interval Exercise on Inflammation and Endothelial Function in Children & Adolescents With Obesity|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821313
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|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|