Football Players Health Study In Person Assessments Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-22

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

How the Elderly Live With Pain in Heart Failure

NCT01794728

Heart Failure

COMPLETED

Brain Function and Perfusion in Patients With Heart Failure

NCT01756014

Heart Failure Dilated Cardiomyopathy Perfusion +2 more

UNKNOWN

ACT-HF: Attention, Cognition and Self-Management in Heart Failure

NCT01064765

Heart Failure

COMPLETED

Biomarker Study: Heart Failure Patients at Risk

NCT05336175

Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV

UNKNOWN PHASE1/PHASE2

Telemedicine Technology Demonstration Project for Heart Failure

NCT02115620

Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Dysfunction Neurocognitive Disease Chronic Pain Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).