CASH- Children Active to Stay Healthy

Inflammation Clinical Trial

— CASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821313
• Other study ID #: IRB12-00197
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: April 23, 2015
• Start date: September 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Inflammation
• Pediatric Obesity

Intervention

Other:
• Moderate exercise

• High Intensity Interval Exercise

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (14)

Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimarães GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk — View Citation

Giordano P, Del Vecchio GC, Cecinati V, Delvecchio M, Altomare M, De Palma F, De Mattia D, Cavallo L, Faienza MF. Metabolic, inflammatory, endothelial and haemostatic markers in a group of Italian obese children and adolescents. Eur J Pediatr. 2011 Jul;17 — View Citation

Haram PM, Kemi OJ, Lee SJ, Bendheim MØ, Al-Share QY, Waldum HL, Gilligan LJ, Koch LG, Britton SL, Najjar SM, Wisløff U. Aerobic interval training vs. continuous moderate exercise in the metabolic syndrome of rats artificially selected for low aerobic capa — View Citation

Hopkins ND, Stratton G, Tinken TM, McWhannell N, Ridgers ND, Graves LE, George K, Cable NT, Green DJ. Relationships between measures of fitness, physical activity, body composition and vascular function in children. Atherosclerosis. 2009 May;204(1):244-9. — View Citation

Kelly AS, Wetzsteon RJ, Kaiser DR, Steinberger J, Bank AJ, Dengel DR. Inflammation, insulin, and endothelial function in overweight children and adolescents: the role of exercise. J Pediatr. 2004 Dec;145(6):731-6. — View Citation

McMurray RG, Zaldivar F, Galassetti P, Larson J, Eliakim A, Nemet D, Cooper DM. Cellular immunity and inflammatory mediator responses to intense exercise in overweight children and adolescents. J Investig Med. 2007 Apr;55(3):120-9. — View Citation

Meyer AA, Kundt G, Lenschow U, Schuff-Werner P, Kienast W. Improvement of early vascular changes and cardiovascular risk factors in obese children after a six-month exercise program. J Am Coll Cardiol. 2006 Nov 7;48(9):1865-70. Epub 2006 Oct 17. — View Citation

Moghadasi M, Mohebbi H, Rahmani-Nia F, Hassan-Nia S, Noroozi H, Pirooznia N. High-intensity endurance training improves adiponectin mRNA and plasma concentrations. Eur J Appl Physiol. 2012 Apr;112(4):1207-14. doi: 10.1007/s00421-011-2073-2. Epub 2011 Jul — View Citation

Norris AL, Steinberger J, Steffen LM, Metzig AM, Schwarzenberg SJ, Kelly AS. Circulating oxidized LDL and inflammation in extreme pediatric obesity. Obesity (Silver Spring). 2011 Jul;19(7):1415-9. doi: 10.1038/oby.2011.21. Epub 2011 Feb 17. — View Citation

Pedrosa C, Oliveira BM, Albuquerque I, Simões-Pereira C, Vaz-de-Almeida MD, Correia F. Metabolic syndrome, adipokines and ghrelin in overweight and obese schoolchildren: results of a 1-year lifestyle intervention programme. Eur J Pediatr. 2011 Apr;170(4): — View Citation

Reinehr T, Kiess W, de Sousa G, Stoffel-Wagner B, Wunsch R. Intima media thickness in childhood obesity: relations to inflammatory marker, glucose metabolism, and blood pressure. Metabolism. 2006 Jan;55(1):113-8. — View Citation

Tjønna AE, Lee SJ, Rognmo Ø, Stølen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slørdahl SA, Kemi OJ, Najjar SM, Wisløff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot s — View Citation

Tjønna AE, Stølen TO, Bye A, Volden M, Slørdahl SA, Odegård R, Skogvoll E, Wisløff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi — View Citation

Tyldum GA, Schjerve IE, Tjønna AE, Kirkeby-Garstad I, Stølen TO, Richardson RS, Wisløff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;5 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The primary outcomes are the percent change in FVR and in inflammatory markers (hsCRP, IL-6, TNF-a, and adiponectin) from pre- to post-intervention in both groups.	Within one month pre and one month post-intervention	No
Secondary	Percent difference in inflammation and endothelial function between moderate and high intensity interval exercise (HIIE) groups.		Within one month pre- and no more than one month post-intervention	No