- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02833129
The Effects of Playing High School Football on Later Life Cognitive Functioning and Mental Health
July 14, 2016 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
3904
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
-- Male.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Collected in 2003-2005 when participants were around 65
|
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.
|
Collected in 2003-2005 when participants were around 65
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Modified CES-D score collected from surveys administered when study subjects were approximately 54 and 72 years old.
|
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
|
Analog of Primary Outcome 2, but based on test results in 2011, when subjects were approximately 72.
|
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
|
Raw scores on the Letter Fluency test (a component of composite measure of cognition) administered in 2003-05 and 2011.
|
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
|
Raw scores from the Delayed Word Recall test administered in 2003-05 and 2011.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
Summary measure of subject's hostility based on survey about how he has felt in the week leading up to interview.
|
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
|
Summary measure of subject's anxiety based on survey about how he has felt in the week leading up to interview.
|
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
|
Summary of subject's anger based on survey about how he has felt in week leading up to interview.
|
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
|
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.
|
Collected in 1992, 2003-05, and 2011 when participants were around 54, 65, and 72, respectively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occupational Prestige Score
Time Frame: Measured in 1975 for jobs held between 1964 and 1975
|
Duncan Socioeconomic Index (SEI) scores for the longest job subject held in 1964, 1970, and 1975.
|
Measured in 1975 for jobs held between 1964 and 1975
|
Total earnings
Time Frame: 1974
|
1974
|
|
Indicator of regular, vigorous physical activity at age 35
Time Frame: Measured in 2011
|
Subjects reported whether they regularly engaged in vigorous physical activity at age 35 during the 2011 survey.
|
Measured in 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sameer Deshpande, University of Pennsylvania
- Principal Investigator: Raiden Hasegawaa, University of Pennsylvania
- Principal Investigator: Dylan S Small, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1957
Primary Completion (Actual)
December 1, 2003
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 11, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Estimate)
July 18, 2016
Last Update Submitted That Met QC Criteria
July 14, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821703
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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