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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01954537
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

Condition or disease
Exertional Heat Illness Hydration Status

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "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."
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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.

Primary Outcome Measures :
  1. Peak core body temperature [ Time Frame: The first 3-4 days of preseason football practice for each cohort. ]
    Measured via HQInc ingestible core thermometer throughout practices.

Secondary Outcome Measures :
  1. Hydration status before and after preseason football practice [ Time Frame: Over first 3-4 days of each cohort's preseason camp. ]
    Measured via urine specific gravity and body weights before and after practice.

  2. Baseline knowledge of hydration status and heat illness in football [ Time Frame: Up to August 30th, 2013 ]
    Athletes will be administered a 14 question survey covering various topics with regards to practice regulation, heat illness, and hydration.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be volunteers from the Minnesota Vikings Professional football team, Bethel University Division III football team, and Roseville High School football team.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01954537

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Austin R Krohn, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01954537     History of Changes
Other Study ID Numbers: 1307M38681
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Exertional heat illness
Hydration Status
Preseason football
heat stroke