Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03866564 |
| Other study ID # |
2018P001929 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2019 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
