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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Wisconsin, Madison
Stanford University
Moss Rehabilitation Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1957

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 821703

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

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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