Brain and Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors

July 6, 2016 updated by: The University of Texas at Dallas

Brain & Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors

Seniors 65 years of age and older represent one of the fastest growing segments of society with the population doubling within the next 25 years with dramatic rates of mental decline, costing society billions of dollars each year. The proposed research seeks to discover whether relatively short term mental or physical training can enhance gist reasoning, generalize to untrained cognitive areas and modify/strengthen brain function in areas susceptible to aging processes. To identify neuroprotective and non-pharmacological interventions to prevent mental decline and maximize cognitive brain health during the course of the adult lifespan has major public policy implications.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: A significant potential exists to modify the structure and function of the aging human brain given intensive mental stimulation and physical activity. Age-related cognitive decline has consistently been identified on frontal lobe measures of executive control such as reasoning. Concomitantly, a greater vulnerability of frontal brain networks, which subserve executive control functions, has also been identified with aging. Preliminary evidence highlights the potential of reasoning training as well as physical training to modify and strengthen brain and cognitive function in seniors. Evidence from our lab indicates that frontally mediated, gist-based reasoning (defined as the ability to combine detail information to construct abstract meanings) offers a promising cognitive domain to train. Extracting gist meaning from the massive amount of incoming information is one of the most vital mental skills a healthy mind achieves. Purpose: This proposal is an innovative study to obtain data regarding the benefits of a (a) novel gist-based reasoning training program or (b) physical training on frontal-lobe mediated cognitive measures of executive control in cognitively normal seniors. The project will also employ newly developed (a) brain measures to chart changes in brain blood flow and connectivity combined with (b) a cognitive activation task specifically designed to measure brain regions engaged in gist reasoning versus detail processing. The project also examines shorter dose effects, i.e. after 6 weeks and 12 weeks, than previously examined as well as individual differences based on high and low performers for gist and physical training. Methods: 60 cognitively normal seniors between the ages of 60 and 75 years will be recruited for study and randomized into 1 of 3 groups. Each group will consist of 20 participants each: a reasoning-trained, a physical-trained and a wait-listed control group. Participants will be comprehensively screened to insure they are cognitively normal. Prior to intervention, participants' baseline gist and detail processing ability, battery of cognitive functions and fitness measures will be obtained. Structural and functional brain measures will also be obtained. Participants will undergo 12 weeks of gist-based training or physical training with measurement at midpoint, 6 weeks of training, endpoint 12 weeks of training and 4 weeks after training is completed. Training effects will be measured behaviorally in trained areas (reasoning & physical) and untrained cognitive areas. Additionally, structural and functional brain imaging will measure changes in cerebral blood flow, global and regional brain volume, white matter tracts, efficiency, activation patterns, and blood oxygenation with a particular focus on changes to frontal regions. Significance: The current study seeks to discover neuroprotective, nonpharmacological interventions that could prevent mental decline and strengthen cognitive brain health in seniors, with possible societal savings of billions of dollars. This will be one of the first training studies to explore short-term intensive reasoning and physical training, each documented as pivotal to cognitive brain health with the potential to strengthen frontal regions against the losses associated with aging.

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.
Interventional

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • The University of Texas at Dallas

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

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study will include 60 cognitively normal seniors between the ages of 60 and 75 years.
  • Participants will have normal IQ, be native speakers of English and have a minimum of high school education.

Exclusion Criteria:

  • Participants with a previous history of stroke, diabetes, untreated hypertension, major surgeries within the past 6 months, major psychiatric disorder, depression or cognitive impairment will be excluded.
  • Additionally, anyone that has a condition that would exclude them from MRI will not be included.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No intervention
Seniors undergo all testing but remain current lifestyle
Experimental: Training
Groups will undergo either physical or mental training. Physical training is 1 hour aerobic training 3 times per week for 12 weeks. Mental training is 1 hour Strategic Memory Advanced Reasoning Training 3 times per week.
Behavioral: SMART- Strategic Memory and Reasoning Training
Teach people to filter out un necessary or unimportant details to enhance mental efficiency. This training will be done over 12 weeks for 3 hours each week.
Other: Physical Exercise
The group with undergo 1 hour of aerobic exercise (at 50-70 % of the participants max oxygen intake) 3 times a week for 12 weeks.

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
Time Frame
Cognitive Scores
Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study
begining (0 weeks), middle (6 weeks) and end (12 weeks) of study

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
Time Frame
MRI images
Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study
begining (0 weeks), middle (6 weeks) and end (12 weeks) of study

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.
The University of Texas at Dallas

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.
National Institutes of Health (NIH)

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: Sandra Chapman, Ph.D., The University of Texas at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2012

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.
June 1, 2013

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.
September 1, 2013

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).
September 14, 2009

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.
September 14, 2009

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.
September 15, 2009

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 11, 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 6, 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.
June 1, 2012

More Information

Terms related to this study

Keywords

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.
  • 07-19
  • NIH 1RC1AG035954-01

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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