Brain and Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors
Primary Purpose
Hearing Impaired
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART- Strategic Memory and Reasoning Training
Physical Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Impaired focused on measuring Healthy Aging, Exercise, Cognition, Cognitive Training, Keeping healthy seniors as mentally efficient as possible
Eligibility Criteria
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.
Sites / Locations
- The University of Texas at Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Training
Arm Description
Seniors undergo all testing but remain current lifestyle
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.
Outcomes
Primary Outcome Measures
Cognitive Scores
Secondary Outcome Measures
MRI images
Full Information
NCT ID
NCT00977418
First Posted
September 14, 2009
Last Updated
July 6, 2016
Sponsor
The University of Texas at Dallas
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00977418
Brief Title
Brain and Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors
Official Title
Brain & Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas at Dallas
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired
Keywords
Healthy Aging, Exercise, Cognition, Cognitive Training, Keeping healthy seniors as mentally efficient as possible
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Seniors undergo all testing but remain current lifestyle
Arm Title
Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMART- Strategic Memory and Reasoning Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
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 Measure Information:
Title
Cognitive Scores
Time Frame
begining (0 weeks), middle (6 weeks) and end (12 weeks) of study
Secondary Outcome Measure Information:
Title
MRI images
Time Frame
begining (0 weeks), middle (6 weeks) and end (12 weeks) of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Chapman, Ph.D.
Organizational Affiliation
The University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29121545
Citation
Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.
Results Reference
derived
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Brain and Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors
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