Football Players Health Study In Person Assessments Study (IPA)

The Football Players Health Study at Harvard University In Person Assessment Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Sleep Apnea; Cardiac Dysfunction; Neurocognitive Disease
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: Neuropsychological Testing; Diagnostic test: Quantitative Sensory Testing; Diagnostic test: Nocturnal Polysomnography

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: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Former Professional American-Style Football Players

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Dysfunction	Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography	Study visit day 3
Neurocognitive Disease	Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.	Study visit day 2
Chronic Pain: Pain Catastrophizing Scale	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	Study visit day 2
Sleep Apnea	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	study visit day 2

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Martinos Center for Biomedical Imaging
• Investigators: Principal Investigator: Meagan M Wasfy, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2018P001929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No