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
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 April 15, 2014