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

Exertional Heat Illness Clinical Trial

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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954537
• Other study ID #: 1307M38681
• Status: Completed
• Phase: N/A
• First received: September 18, 2013
• Last updated: September 26, 2013
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exertional Heat Illness
• Hydration Status

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak core body temperature	Measured via HQInc ingestible core thermometer throughout practices.	The first 3-4 days of preseason football practice for each cohort.	Yes
Secondary	Hydration status before and after preseason football practice	Measured via urine specific gravity and body weights before and after practice.	Over first 3-4 days of each cohort's preseason camp.	Yes
Secondary	Baseline knowledge of hydration status and heat illness in football	Athletes will be administered a 14 question survey covering various topics with regards to practice regulation, heat illness, and hydration.	Up to August 30th, 2013	No