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
  Purpose

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
Exertional Heat Illness
Hydration Status

Study Type: Observational
Study Design: 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."

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: July 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   14 Years and older
Genders 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954537

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

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01954537     History of Changes
Other Study ID Numbers: 1307M38681
Study First Received: September 18, 2013
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014