Cardiac DysfunctionIPANCT03866564
Football Players Health Study In Person Assessments Study
An observational study of Cardiac Dysfunction and Neurocognitive Disease, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain
- What is being tested?
- Echocardiography, Neuropsychological Testing and Quantitative Sensory Testing
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Former Professional American-Style Football Players
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain, Sleep Apnea
- Being tested
- Echocardiography, Neuropsychological Testing, Quantitative Sensory Testing, Nocturnal Polysomnography
- Medical subject headings
- Chronic Pain, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Cardiac ultrasound to measure left ventricular systolic function.
Neuropsychological TestingDiagnostic test
Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
Quantitative Sensory TestingDiagnostic test
Clinically accepted quantitative assessment of chronic pain burden.
Nocturnal PolysomnographyDiagnostic test
Routine overnight sleep study to measure apnea-hypopnea index.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography | |
| 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). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography | |
| 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). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Dysfunction
Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography
Measured: Study visit day 3
Neurocognitive Disease
Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.
Measured: 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
Measured: 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
Measured: study visit day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start22 Apr 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DysfunctionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, Martinos Center for Biomedical Imaging, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Meagan Murphy Wasfy, Massachusetts General Hospital
- Investigators
- Meagan M Wasfy, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866564
- Sponsor's protocol ID
- 2018P001929
- Acronym
- IPA
- Status last verified
- Mar 2024
- First submitted
- 19 Jan 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Football Players Health Study at Harvard University In Person Assessment Study
- ClinicalTrials.gov ID
- NCT03866564
- Acronym / sponsor ID
- IPA / 2018P001929
- Conditions
- Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, Martinos Center for Biomedical Imaging, Brigham and Women's Hospital
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-Afflicted | – | Diagnostic Test: Echocardiography, Diagnostic Test: Neuropsychological Testing, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Nocturnal PolysomnographyParticipants 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). |
| Un-Afflicted | – | Diagnostic Test: Echocardiography, Diagnostic Test: Neuropsychological Testing, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Nocturnal PolysomnographyParticipants 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). |
| Single Afflicted | – | Diagnostic Test: Echocardiography, Diagnostic Test: Neuropsychological Testing, Diagnostic Test: Quantitative Sensory Testing, Diagnostic Test: Nocturnal PolysomnographyParticipants 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). |
Who may qualify
- Ages
- 24 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Former Professional American-Style Football Players
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyCardiac ultrasound to measure left ventricular systolic function. | Diagnostic test | Multi-Afflicted, Single Afflicted, Un-Afflicted |
| Neuropsychological TestingStandard clinical testing designed to establish or exclude the presence of cognitive dysfunction. | Diagnostic test | Multi-Afflicted, Single Afflicted, Un-Afflicted |
| Quantitative Sensory TestingClinically accepted quantitative assessment of chronic pain burden. | Diagnostic test | Multi-Afflicted, Single Afflicted, Un-Afflicted |
| Nocturnal PolysomnographyRoutine overnight sleep study to measure apnea-hypopnea index. | Diagnostic test | Multi-Afflicted, Single Afflicted, Un-Afflicted |
Primary outcome
Cardiac Dysfunction
Time frame: Study visit day 3
Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography
Neurocognitive Disease
Time frame: Study visit day 2
Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.
Chronic Pain: Pain Catastrophizing Scale
Time frame: 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
Time frame: study visit day 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meagan M Wasfy, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Dysfunction and Neurocognitive Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Dysfunction (time frame: Study visit day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.