Memory ImpairmentNCT02833129
The Effects of Playing High School Football on Later Life Cognitive Functioning and Mental Health
An observational study of Memory Impairment and Executive Dysfunction, run by University of Pennsylvania.
Trial summary
The purpose of this study is to assess the effect of playing high school football on later in life cognitive functioning and mental health. This is an observational study that will use data from the Wisconsin Longitudinal Study to compare high school football playing graduates in 1957 with comparable non-high school… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Memory Impairment, Executive Dysfunction, Depression
- How many people
- 3,904 participants
- Where
- No sites listed yet
- Study dates
- Jan 1957to Dec 2011
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Graduates of Wisconsin high schools in 1957. The data comes from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957.
Who may be able to join
- -- Male.
Who cannot join
- No yearbook information available to determine football playing status
- Activity participation in yearbook was not recorded under senior photo or in an index.
- Did not played football but played another high contact sport (soccer, hockey, lacrosse or wrestling).
About this study
Official title: The Effects of Playing High School Football on Later Life Cognitive Functioning and Mental Health: An Observational Study
The purpose of this study is to assess the effect of playing high school football on later in life cognitive functioning and mental health. This is an observational study that will use data from the Wisconsin Longitudinal Study to compare high school football playing graduates in 1957 with comparable non-high school football playing graduates on cognitive functioning and mental health measures when participants are in their 60s.
Read the detailed description
The investigators will use data from the Wisconsin Longitudinal Study (WLS) of graduates from Wisconsin high schools in 1957 to investigate the link between playing high-school football and later life depression and cognitive impairment. The WLS has a number of attractive features that make it well-suited for such a study. First, it records whether study participants participated in high school football and also includes detailed measurements of later-life mental health, psychological well-being, and cognition. Second, it includes a rich set of baseline covariates which the investigators will use to construct matched sets of treated and control individuals, including family background, adolescent characteristics, educational and occupational achievement and aspirations. Third, the WLS is one of the few longitudinal data sets that includes an administrative measure of childhood cognition. In short, the WLS provides a large data set that facilitates comparing the later life mental health and cognitive ability of men who played high school football to those who did not, after carefully controlling for a range of potential confounders. The investigators will compare the primary outcomes of the treated subjects to the primary outcomes of the control subjects, after controlling for baseline covariates via full matching with a propensity score caliper. The primary outcomes are depression (modified CES-D score) and cognitive functioning (average of z-scores for letter fluency and delayed word recall) when participants are age 65. Secondary outcomes that include cognitive scores on various domains, the Spielberger anger index, the Spielberger anxiety index and a hostility index will also be analyzed.
- Conditions
- Memory Impairment, Executive Dysfunction, Depression
- Medical subject headings
- Memory Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary score of psychological distress/depression at age 65
Modified CES-D (Center for Epidemiologic Studies Depression Scale) score collected from survey administered when study subjects were approximately 65 years old.
Measured: Collected in 2003-2005 when participants were around 65
Composite measure of cognition at age 65
Average of the standardized scores from two cognitive functioning tests. In the first test, Letter Fluency, which measures executive functioning, subjects were asked to name as many words beginning with "L" or "F" as they could in 60 seconds. In the second, Delayed Word Recall, which measures memory and attention, subjects were told a list of 10 words and asked to recall as many as possible 12minutes later.
Measured: Collected in 2003-2005 when participants were around 65
Secondary outcomes (12)
Summary score of psychological distress/depression at ages 54 and 72
Modified CES-D score collected from surveys administered when study subjects were approximately 54 and 72 years old.
Measured: Collected in 1992 and 2011 when participants were around 54 and 72 respectively
Composite measure of cognition at age 72
Analog of Primary Outcome 2, but based on test results in 2011, when subjects were approximately 72.
Measured: Collected in 2011 when participants were around 72
Score on Letter Fluency test at ages 65 and 72
Raw scores on the Letter Fluency test (a component of composite measure of cognition) administered in 2003-05 and 2011.
Measured: Collected in 2003-2005 and 2011 were around 65 and 72 respectively
Score on Delayed Word Recall test at ages 65 and 72
Raw scores from the Delayed Word Recall test administered in 2003-05 and 2011.
Measured: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Score on Wechsler Adult Intelligence Scale Similarities test at ages 54, 65, and 72
Subjects were asked to describe how two objects from a given list of 9 pairs were alike. Their responses were scored on a fixed scale. For instance, if asked to describe how an orange or a banana are alike, the response "both are fruits" received the highest score (2 points), "both may be eaten" received 1 point, and "both are sweet" received 0 points.
Measured: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Score on Digit Order test at ages 65 and 72
Subjects were asked to mentally rearrange and verbally restate increasingly lengthy sets of one-digit numbers such that they are value-ordered from lowest to highest.
Measured: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Score on McArdle & Woodcock number series test at age 72
Subjects were given a sequence of numbers (e.g. 23, 26, 30, 35, --) and asked to identify the number that correctly completed the sequence. This test is a measure of induction and reasoning, with particular emphasis on quantitative reasoning.
Measured: Collected in 2011 when participants were around 72
Score on Immediate Word Recall test at ages 65 and 72
Subjects were read 10 words and asked to immediately recall as many as they can. The same set of words is used in the Delayed Word Recall test.
Measured: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Hostility index at ages 65 and 72
Summary measure of subject's hostility based on survey about how he has felt in the week leading up to interview.
Measured: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Spielberger anxiety index
Summary measure of subject's anxiety based on survey about how he has felt in the week leading up to interview.
Measured: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Spielberger anger index
Summary of subject's anger based on survey about how he has felt in week leading up to interview.
Measured: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Indicator of heavy drinking status at ages 54, 65, and 72
A subject is classified as a heavy drinker if he reports having had more than 5 drinks on more than five separate occasions in the month preceding the interview. Based on their responses to the interview, a binary indicator of whether the subject is a heavy drinker was constructed.
Measured: Collected in 1992, 2003-05, and 2011 when participants were around 54, 65, and 72, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 1957
- Primary completionDec 2003
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Retrospective
- Enrolment
- 3,904 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, Moss Rehabilitation Research Institute, Stanford University
- Responsible party
- Sponsor
- Investigators
- Sameer Deshpande, Principal investigator, University of PennsylvaniaRaiden Hasegawaa, Principal investigator, University of PennsylvaniaDylan S Small, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833129
- Sponsor's protocol ID
- 821703
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Playing High School Football on Later Life Cognitive Functioning and Mental Health: An Observational Study
- ClinicalTrials.gov ID
- NCT02833129
- Acronym / sponsor ID
- 821703
- Conditions
- Memory Impairment, Executive Dysfunction, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,904 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, Moss Rehabilitation Research Institute, Stanford University
- Study start
- Jan 1957
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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 purpose of this study is to assess the effect of playing high school football on later in life cognitive functioning and mental health. This is an observational study that will use data from the Wisconsin Longitudinal Study to compare high school football playing graduates in 1957 with comparable non-high school football playing graduates on cognitive functioning and mental health measures when participants are in their 60s.
Detailed description
The investigators will use data from the Wisconsin Longitudinal Study (WLS) of graduates from Wisconsin high schools in 1957 to investigate the link between playing high-school football and later life depression and cognitive impairment. The WLS has a number of attractive features that make it well-suited for such a study. First, it records whether study participants participated in high school football and also includes detailed measurements of later-life mental health, psychological well-being, and cognition. Second, it includes a rich set of baseline covariates which the investigators will use to construct matched sets of treated and control individuals, including family background, adolescent characteristics, educational and occupational achievement and aspirations. Third, the WLS is one of the few longitudinal data sets that includes an administrative measure of childhood cognition. In short, the WLS provides a large data set that facilitates comparing the later life mental health and cognitive ability of men who played high school football to those who did not, after carefully controlling for a range of potential confounders. The investigators will compare the primary outcomes of the treated subjects to the primary outcomes of the control subjects, after controlling for baseline covariates via full matching with a propensity score caliper. The primary outcomes are depression (modified CES-D score) and cognitive functioning (average of z-scores for letter fluency and delayed word recall) when participants are age 65. Secondary outcomes that include cognitive scores on various domains, the Spielberger anger index, the Spielberger anxiety index and a hostility index will also be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Graduates of Wisconsin high schools in 1957. The data comes from the Wisconsin Longitudinal Study (WLS), a long-term study of a random sample of 10,317 men and women who graduated from Wisconsin high schools in 1957.
Key inclusion criteria (1 listed)
- -- Male.
Key exclusion criteria (3 listed)
- No yearbook information available to determine football playing status
- Activity participation in yearbook was not recorded under senior photo or in an index.
- Did not played football but played another high contact sport (soccer, hockey, lacrosse or wrestling).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Summary score of psychological distress/depression at age 65
Time frame: Collected in 2003-2005 when participants were around 65
Modified CES-D (Center for Epidemiologic Studies Depression Scale) score collected from survey administered when study subjects were approximately 65 years old.
Composite measure of cognition at age 65
Time frame: Collected in 2003-2005 when participants were around 65
Average of the standardized scores from two cognitive functioning tests. In the first test, Letter Fluency, which measures executive functioning, subjects were asked to name as many words beginning with "L" or "F" as they could in 60 seconds. In the second, Delayed Word Recall, which measures memory and attention, subjects were told a list of 10 words and asked to recall as many as possible 12minutes later.
12 secondary outcomes
Summary score of psychological distress/depression at ages 54 and 72
Time frame: Collected in 1992 and 2011 when participants were around 54 and 72 respectively
Composite measure of cognition at age 72
Time frame: Collected in 2011 when participants were around 72
Score on Letter Fluency test at ages 65 and 72
Time frame: Collected in 2003-2005 and 2011 were around 65 and 72 respectively
Score on Delayed Word Recall test at ages 65 and 72
Time frame: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Score on Wechsler Adult Intelligence Scale Similarities test at ages 54, 65, and 72
Time frame: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Score on Digit Order test at ages 65 and 72
Time frame: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Score on McArdle & Woodcock number series test at age 72
Time frame: Collected in 2011 when participants were around 72
Score on Immediate Word Recall test at ages 65 and 72
Time frame: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Hostility index at ages 65 and 72
Time frame: Collected in 2003-2005 and 2011 when participants were around 65 and 72 respectively
Spielberger anxiety index
Time frame: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Spielberger anger index
Time frame: Collected in 1992, 2003-2005 and 2011 when participants were around 54, 65 and 72 respectively
Indicator of heavy drinking status at ages 54, 65, and 72
Time frame: Collected in 1992, 2003-05, and 2011 when participants were around 54, 65, and 72, respectively
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 18 Jul 2016.
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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.
Sameer Deshpande principal investigator
University of Pennsylvania
Raiden Hasegawaa principal investigator
University of Pennsylvania
Dylan S Small, PhD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Impairment and Executive Dysfunction, run by University of Pennsylvania.
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 1 inclusion and 3 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 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Summary score of psychological distress/depression at age 65 (time frame: Collected in 2003-2005 when participants were around 65). The study lists 2 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 18 Jul 2016.