Clinical trial NCT01954537: Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exertional Heat Illness
Hydration Status
Keywords: Exertional heat illness
Hydration Status
Preseason football
heat stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 22
Sex: MALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak core body temperature
timeFrame: The first 3-4 days of preseason football practice for each cohort.
Secondary outcomes:
measure: Hydration status before and after preseason football practice
timeFrame: Over first 3-4 days of each cohort's preseason camp.
measure: Baseline knowledge of hydration status and heat illness in football
timeFrame: Up to August 30th, 2013
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Austin R Krohn, MD
role: PRINCIPAL_INVESTIGATOR
References: