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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977418
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : July 11, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
The University of Texas at Dallas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hearing Impaired Behavioral: SMART- Strategic Memory and Reasoning Training Other: Physical Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Brain & Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.
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.

Primary Outcome Measures :
  1. Cognitive Scores [ Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study ]

Secondary Outcome Measures :
  1. MRI images [ Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977418

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United States, Texas
The University of Texas at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
The University of Texas at Dallas
National Institutes of Health (NIH)
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Principal Investigator: Sandra Chapman, Ph.D. The University of Texas at Dallas
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The University of Texas at Dallas Identifier: NCT00977418    
Other Study ID Numbers: 07-19
NIH 1RC1AG035954-01
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: June 2012
Keywords provided by The University of Texas at Dallas:
Healthy Aging
Cognitive Training
Keeping healthy seniors as mentally efficient as possible
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms