IPA: Football Players Health Study In Person Assessments Study
Study Details
Study Description
Brief Summary
The aim of the Football Players Health Study (FPHS) is to advance the understanding of the complex and inter-related pathways that can develop into player related illness and disability. Former National Football League players will be given the opportunity to undergo 2&1/2 days of rigorous assessment in the areas of Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain, and Sleep Apnea to attempt to define the pathology among former professional athletes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Diagnostic Test: Echocardiography
Cardiac ultrasound to measure left ventricular systolic function.
Diagnostic Test: Neuropsychological Testing
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Diagnostic Test: Quantitative Sensory Testing
Clinically accepted quantitative assessment of chronic pain burden.
Diagnostic Test: Nocturnal Polysomnography
Routine overnight sleep study to measure apnea-hypopnea index.
|
| 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). |
Diagnostic Test: Echocardiography
Cardiac ultrasound to measure left ventricular systolic function.
Diagnostic Test: Neuropsychological Testing
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Diagnostic Test: Quantitative Sensory Testing
Clinically accepted quantitative assessment of chronic pain burden.
Diagnostic Test: Nocturnal Polysomnography
Routine overnight sleep study to measure apnea-hypopnea index.
|
| 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). |
Diagnostic Test: Echocardiography
Cardiac ultrasound to measure left ventricular systolic function.
Diagnostic Test: Neuropsychological Testing
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Diagnostic Test: Quantitative Sensory Testing
Clinically accepted quantitative assessment of chronic pain burden.
Diagnostic Test: Nocturnal Polysomnography
Routine overnight sleep study to measure apnea-hypopnea index.
|
Outcome Measures
Primary Outcome Measures
- Cardiac Dysfunction [Study visit day 3]
Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography
- Neurocognitive Disease [Study visit day 2]
Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.
- Chronic Pain: Pain Catastrophizing Scale [Study visit day 2]
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
- Sleep Apnea [study visit day 2]
Measurement of the Apnea-Hypopnea Index via Conventional Nocturnal Polysomnography. The Apnea-Hpopnea 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Harvard Medical School (HMS and HSDM)
- Beth Israel Deaconess Medical Center
- Martinos Center for Biomedical Imaging
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Aaron L Baggish, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018P001929