Fitness Training in Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Wisconsin, Madison.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Wisconsin, Madison
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205296
First received: September 12, 2005
Last updated: October 29, 2008
Last verified: October 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | October 29, 2008 | ||||
| Start Date ICMJE | March 2002 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
maximal VO2 levels [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00205296 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
fasting insulin and glucose levels [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
fasting insulin and glucose levels | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fitness Training in Children | ||||
| Official Title ICMJE | Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children | ||||
| Brief Summary | We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: exercise
this will test the effect of exercise on insulin sensitivity, fitness and body composition |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 360 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 16 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00205296 | ||||
| Other Study ID Numbers ICMJE | 2002-090 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Aaron Carrel, University of Wisconsin | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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