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OpenTrials
Completed

NCT Number: NCT01954537

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

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Key information

Age range

14 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Any athlete weighing less than eighty (80) pounds.
  • Any athlete with any known or suspected diseases of the gastrointestinal tract.
  • Any athlete with impairment of the gag reflex.
  • Any athlete with previous gastrointestinal surgery.
  • Any athlete with history of problems with their esophagus.
  • Any athlete who might undergo an MRI scan before the temperature sensor has been eliminated from the body.
  • Any athlete with problems moving food through their gastrointestinal tract.
  • Any athlete having a cardiac pacemaker or other implanted electro medical device.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study 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."

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2013
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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