Football Players Health Study In Person Assessments Study (IPA)
The Football Players Health Study at Harvard University In Person Assessment Study
Study Overview
Status
Detailed Description
Little is known about the long term health impacts of being exposed to a career in professional football. The primary objective of this study is to assess the relationship between affliction definitions, as subjectively described by participants in the first phase of the study (Q1), and objective pathology as defined by standard of care clinical and investigational testing. An exploratory secondary objective of this study is to examine the relationships between exposure to football, defined within the parameters of how old was the participant when their career started, how long did they play professional football, what was the participants field position and objective pathology defined as standard of clinical care.
The questions the study hopes to answer are as follows: 1) Are subjective complaints among former professional football players associated with objective evidence of pathology as measured by clinically accepted diagnostic testing (Primary objective), and 2) Is exposure to professional football, as defined by variables including career duration and player field position, associated with cardiac dysfunction, neurocognitive disease, chronic pain, and sleep apnea (Secondary objective).
This protocol has been constructed with an emphasis on reducing risk and maximizing yield. The Investigators who will be performing the assessments across the Harvard Medical School Institutions have worked together to minimize potential risk exposure by carefully selecting imaging protocols that limit radiation exposure, keeping phlebotomy limited, and by conducting these assessments under the supervision of investigators with established track records for conducting safe and effective human subject research.
The study visit will occur over 2&1/2 days. All costs of transportation, lodging, and meals will be covered by the study. All participants will have the assistance of a Study Navigator, a member of the FPHS staff who will accompany the participant. This navigator will assure that the participant gets to each assessment, helps to make decisions regarding scheduling issues or conflicts, assesses the need for additional breaks, and acts as a resource and guide for the participant throughout the study. The navigator will be in communication with key members of the research team for real time decision making (aborting or skipping an assessment).
Participants will be advised that results from these assessments are research results and are not meant for any diagnosis of disease. However, assessment results will be given to the participant if they wish to receive them. Any incidental finding that may have clinical relevance will be explained by a Study Physician and the Medical Navigation Nurse, and the participant will be assisted in obtaining follow up care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 24-55 at the time of first Health and Wellness Questionnaire (Q1) completion.
- Former professional football player who played between 1960 to present.
- Prior completed the first Health and Wellness Questionnaire (Q1)
- "Healthy" subjects: ability to give informed consent and comply with study procedures.
- "Afflicted" participants: must meet criteria for at least one of the following subjective afflictions based on Q1 responses: 1) Cardiovascular Dysfunction, 2) Neurocognitive Disease, 3) Chronic Pain, and/or 4) Sleep Apnea
Exclusion Criteria:
- Prior metallic device implants such as cardiac pacemakers/defibrillators or perfusion pumps that cannot be removed.
- Ferromagnetic implants or objects that cannot be removed such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants or jewelry
- Body weight >390 lbs at screening
- Inability to complete the telephone screener
- Low T-MoCA score (<17) and absence of an available study partner if required following MD review.
- Significant behavioral or functional disability due to cognitive impairment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Multi-Afflicted
Participants with multiple self reported afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).
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Cardiac ultrasound to measure left ventricular systolic function.
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Clinically accepted quantitative assessment of chronic pain burden.
Routine overnight sleep study to measure apnea-hypopnea index.
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Un-Afflicted
Participants who report no afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).
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Cardiac ultrasound to measure left ventricular systolic function.
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Clinically accepted quantitative assessment of chronic pain burden.
Routine overnight sleep study to measure apnea-hypopnea index.
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Single Afflicted
Participants with one self reported afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).
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Cardiac ultrasound to measure left ventricular systolic function.
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Clinically accepted quantitative assessment of chronic pain burden.
Routine overnight sleep study to measure apnea-hypopnea index.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardiac Dysfunction
Time Frame: Study visit day 3
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Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography
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Study visit day 3
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Neurocognitive Disease
Time Frame: Study visit day 2
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Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.
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Study visit day 2
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Chronic Pain: Pain Catastrophizing Scale
Time Frame: Study visit day 2
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Performance on Pain Catastrophizing Scale to Quantify the Magnitude of Chronic Pain.
The range of this scale is from 0 to 52.
The higher the score, the higher the presence of catastrophizing thoughts.
A score of 30 or greater will be used to determine magnitude of pain that is clinically relevant
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Study visit day 2
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Sleep Apnea
Time Frame: study visit day 2
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Measurement of the Apnea-Hypopnea Index via Conventional Nocturnal Polysomnography.
The Apnea-Hypopnea Index (AHI) is the measure of the number of apnea or hypopnea events measured in a one hour period.
0-5 events are normal, 6-15 events indicate mild sleep apnea, 16-30 events indicate moderate sleep apnea, over 30 events indicate sever sleep apnea.
Scores of >15 will be considered positive for sleep apnea
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study visit day 2
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Meagan M Wasfy, MD, MPH, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001929
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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