Exertional Heat IllnessNCT01954537
Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels
An observational study of Exertional Heat Illness and Hydration Status, run by University of Minnesota.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exertional Heat Illness, Hydration Status
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
About this study
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."
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.
Read the 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.
- Conditions
- Exertional Heat Illness, Hydration Status
- Keywords
- Exertional heat illness, Hydration Status, Preseason football, heat stroke
- Medical subject headings
- Heat Stress Disorders, Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Peak core body temperature
Measured via HQInc ingestible core thermometer throughout practices.
Measured: The first 3-4 days of preseason football practice for each cohort.
Secondary outcomes (2)
Hydration status before and after preseason football practice
Measured via urine specific gravity and body weights before and after practice.
Measured: Over first 3-4 days of each cohort's preseason camp.
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.
Measured: Up to August 30th, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exertional Heat IllnessStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin R Krohn, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954537
- Sponsor's protocol ID
- 1307M38681
- Status last verified
- Sep 2013
- First submitted
- 18 Sep 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT01954537
- Acronym / sponsor ID
- 1307M38681
- Conditions
- Exertional Heat Illness, Hydration Status
- Keywords
- Exertional heat illness, Hydration Status, Preseason football, heat stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Hydration status before and after preseason football practice
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin R Krohn, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Exertional Heat Illness and Hydration Status, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak core body temperature (time frame: The first 3-4 days of preseason football practice for each cohort.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.