- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977418
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
Texas
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Dallas, Texas, United States, 75235
- The University of Texas at Dallas
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-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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
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
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.
Collaborators
Investigators
- 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.
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
June 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
September 14, 2009
First Submitted That Met QC Criteria
September 14, 2009
First Posted (Estimate)
September 15, 2009
Study Record Updates
Last Update Posted (Estimate)
July 11, 2016
Last Update Submitted That Met QC Criteria
July 6, 2016
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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