- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954537
Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels
September 26, 2013 updated by: University of Minnesota
"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."
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
22
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The first 3-4 days of preseason football practice for each cohort.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Over first 3-4 days of each cohort's preseason camp.
|
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.
|
Up to August 30th, 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Austin R Krohn, MD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
September 18, 2013
First Submitted That Met QC Criteria
September 26, 2013
First Posted (Estimate)
October 1, 2013
Study Record Updates
Last Update Posted (Estimate)
October 1, 2013
Last Update Submitted That Met QC Criteria
September 26, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1307M38681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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