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

NCT ID: NCT01954537

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Exertional Heat Illness Hydration Status

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exertional heat illness Hydration Status Preseason football heat stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Professional football players

Offensive and defensive professional football players ranging in age from 22 to 30 years old.

No interventions assigned to this group

Collegiate Football Players

Division III collegiate football players ranging in age from 20 to 23 years old.

No interventions assigned to this group

High School Football Players

High school football players ranging in age from 16 to 18 years old.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Football player on one of the teams from the pre-selected teams. Male.

Exclusion Criteria

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.
Minimum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Austin R Krohn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1307M38681

Identifier Type: -

Identifier Source: org_study_id