Clinical trial NCT03866564: Football Players Health Study In Person Assessments Study
Official title: The Football Players Health Study at Harvard University In Person Assessment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Dysfunction
Neurocognitive Disease
Chronic Pain
Sleep Apnea
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Beth Israel Deaconess Medical Center
name: Martinos Center for Biomedical Imaging
name: Brigham and Women's Hospital
First posted: 2019-03-07
Enrollment: 111
Sex: MALE
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former Professional American-Style Football Players

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.

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.

Eligibility 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

Primary outcomes:
measure: Cardiac Dysfunction
timeFrame: Study visit day 3
measure: Neurocognitive Disease
timeFrame: Study visit day 2
measure: Chronic Pain: Pain Catastrophizing Scale
timeFrame: Study visit day 2
measure: Sleep Apnea
timeFrame: study visit day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Meagan M Wasfy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: