Clinical Trial: Rhabdomyolysis in Basic Training
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Rhabdomyolysis in Basic Training
Brief Summary:
The purpose of this study is to:
- develop a normative database for serum creatine kinase (CK) responses to basic military training (BMT);
- determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of recruits undergoing BMT;
- assess the impact of climate on the incidence of ER during BMT;
- determine the incidence of candidate genes that may be associated with an increased risk of ER.
Detailed Summary:
Based on our review of scientific information, we have identified several genetic varieties or polymorphisms that may be associated with an increased risk of muscle injury and/or heat illness. As part of our recruitment process we have provided you with this written study information, and will present to you a brief oral and PowerPoint presentation of the study design and schedule, and the time to address any questions not yet answered prior to issuing consent forms for those agreeing to participate.
Participation in this study is entirely voluntary; either agreeing or refusing to participate will have absolutely no effect on your status as a recruit or your standing in basic training. You will not be paid for your participation in this study. While your drill sergeant and company commander will be aware of all those who are participating in the study, this will occur only for scheduling purposes so that you and fellow participants can be excused for the 3 blood draws that will take place after basic physical training has begun. When you consent to participate in this study, you may place limitations on the use of your blood sample by selecting one of the options provided on the last page of the consent form. If at any point you decide not to continue in the study, detailed instructions for withdrawal are in the consent form.
Potential Risks: Participation in this study itself will not increase your risk of developing rhabdomyolysis. If you or any other participant should develop either rhabdomyolysis or very high CK levels, we will perform additional DNA analyses for certain conditions associated with exercise intolerance. Several of these are inherited muscle diseases that may not be diagnosed until adulthood and may only first become apparent after an episode of exercise intolerance. Diagnosis of any of these conditions
Sponsor: Martin Army Community Hospital
Current Primary Outcome: Exertional Rhabdomyolysis [ Time Frame: Day 0, 3, 7 and 14 of basic training ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Martin Army Community Hospital
Dates:
Date Received: January 14, 2008
Date Started: January 2008
Date Completion:
Last Updated: April 18, 2012
Last Verified: April 2012
