Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01954537
First received: September 18, 2013
Last updated: September 26, 2013
Last verified: September 2013

September 18, 2013
September 26, 2013
July 2013
August 2013   (final data collection date for primary outcome measure)
Peak core body temperature [ Time Frame: The first 3-4 days of preseason football practice for each cohort. ] [ Designated as safety issue: Yes ]
Measured via HQInc ingestible core thermometer throughout practices.
Same as current
Complete list of historical versions of study NCT01954537 on ClinicalTrials.gov Archive Site
  • Hydration status before and after preseason football practice [ Time Frame: Over first 3-4 days of each cohort's preseason camp. ] [ Designated as safety issue: Yes ]
    Measured via urine specific gravity and body weights before and after practice.
  • Baseline knowledge of hydration status and heat illness in football [ Time Frame: Up to August 30th, 2013 ] [ Designated as safety issue: No ]
    Athletes will be administered a 14 question survey covering various topics with regards to practice regulation, heat illness, and hydration.
Same as current
Not Provided
Not Provided
 
Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels
"Using Peak Core Temperature in Hot Preseason American Football Practice to Compare and Contrast Risk of Heat Illness at High School, College, and Professional Levels."

To collect field data in professional, collegiate, and high school football players to determine how they respond physiologically to the rigors of preseason training environment. Investigators will compare core temperature, hydration status, practice guidelines regarding rest and hydration, and baseline knowledge of heat illness and hydration among the three levels. The hypothesis is higher peak temperatures will be observed in the younger less experienced football players.

Observations will occur over a 4-5 day period at the start of pre-season training camp. Researchers will meet with the high school volunteers and their parents to discuss the study and obtain informed consent prior to participating. Participants will swallow the HQInc CorTemp pill at least three hours (or late the night before) before practice. Temperature readings will be scanned every 15-30 minutes throughout practice. Pre and post practice weights will be recorded as well as urine specific gravity to help assess hydration status. Participants will also fill out a short 1 page questionnaire regarding their prior heat acclimatization, sleep habits, and baseline knowledge of hydration and heat illness. Protocol will be the same at all three age/competition levels.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects will be volunteers from the Minnesota Vikings Professional football team, Bethel University Division III football team, and Roseville High School football team.

  • Exertional Heat Illness
  • Hydration Status
Not Provided
  • Professional football players
    Offensive and defensive professional football players ranging in age from 22 to 30 years old.
  • Collegiate Football Players
    Division III collegiate football players ranging in age from 20 to 23 years old.
  • High School Football Players
    High school football players ranging in age from 16 to 18 years old.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Football player on one of the teams from the pre-selected teams. Male.

Exclusion Criteria: based on being able to swallow HQInc CorTemp Pill

  1. Any athlete weighing less than eighty (80) pounds.
  2. Any athlete with any known or suspected diseases of the gastrointestinal tract.
  3. Any athlete with impairment of the gag reflex.
  4. Any athlete with previous gastrointestinal surgery.
  5. Any athlete with history of problems with their esophagus.
  6. Any athlete who might undergo an MRI scan before the temperature sensor has been eliminated from the body.
  7. Any athlete with problems moving food through their gastrointestinal tract.
  8. Any athlete having a cardiac pacemaker or other implanted electro medical device.
Male
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01954537
1307M38681
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Austin R Krohn, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP