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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by The University of Texas at Dallas.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
The University of Texas at Dallas
ClinicalTrials.gov Identifier:
NCT00977418
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Elderly
Behavioral: SMART- Strategic Memory and Reasoning Training
Other: Physical Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Brain & Cognitive Changes After Reasoning or Physical Training in Cognitively Normal Seniors

Resource links provided by NLM:


Further study details as provided by The University of Texas at Dallas:

Primary Outcome Measures:
  • Cognitive Scores [ Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI images [ Time Frame: begining (0 weeks), middle (6 weeks) and end (12 weeks) of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Seniors undergo all testing but remain current lifestyle
Experimental: Training
Groups will undergo either physical or mental training.
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977418

Contacts
Contact: Molly Keebler 214-905-3007

Locations
United States, Texas
The University of Texas at Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Sandra Chapmax, Ph.D.         
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
Principal Investigator: Sandra Chapman, Ph.D. The University of Texas at Dallas
  More Information

No publications provided

Responsible Party: Sandra Chapman, Ph.D., The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT00977418     History of Changes
Other Study ID Numbers: 07-19, NIH 1RC1AG035954-01
Study First Received: September 14, 2009
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas at Dallas:
Healthy Aging
Exercise
Cognition
Cognitive Training
Keeping healthy seniors as mentally efficient as possible

ClinicalTrials.gov processed this record on July 31, 2014