Rhabdomyolysis in Basic Training

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rodney S. Gonzalez, MD, Martin Army Community Hospital
ClinicalTrials.gov Identifier:
NCT00601029
First received: January 14, 2008
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to:

  1. develop a normative database for serum creatine kinase (CK) responses to basic military training (BMT);
  2. determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of recruits undergoing BMT;
  3. assess the impact of climate on the incidence of ER during BMT;
  4. determine the incidence of candidate genes that may be associated with an increased risk of ER.

Condition
Exertional Rhabdomyolysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rhabdomyolysis in Basic Training

Further study details as provided by Martin Army Community Hospital:

Primary Outcome Measures:
  • Exertional Rhabdomyolysis [ Time Frame: Day 0, 3, 7 and 14 of basic training ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum and stored blood


Enrollment: 499
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Winter Phase - Observational
2
Summer Phase - Observational

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Military Basic Trainee at Ft. Benning undergoing Infantry Basic Training Male > 18 years old

Criteria

Inclusion Criteria:

  • Enrolled in Basic Training at Ft. Benning
  • Between the ages of 18 and 45
  • Active Duty
  • Able to speak and read English
  • Held in inprocessing seven days or less

Exclusion Criteria:

  • A no answer to any of the above inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601029

Locations
United States, Georgia
Martin Army Community Hospital
Ft. Benning, Georgia, United States, 31905
Sponsors and Collaborators
Martin Army Community Hospital
Investigators
Principal Investigator: Rodney S Gonzalez, MD Martin Army Community Hospital
  More Information

No publications provided

Responsible Party: Rodney S. Gonzalez, MD, Chief, Warrior Care, Martin Army Community Hospital
ClinicalTrials.gov Identifier: NCT00601029     History of Changes
Other Study ID Numbers: DDEAMC 07-25, USUHS G192FP, CIRO 2007522
Study First Received: January 14, 2008
Last Updated: April 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Martin Army Community Hospital:
Exertional Rhabdomyolysis

Additional relevant MeSH terms:
Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014