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

Hearing Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977418
• Other study ID #: 07-19
• Secondary ID: NIH 1RC1AG035954
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: July 6, 2016
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2012
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas at Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Dallas	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Scores		begining (0 weeks), middle (6 weeks) and end (12 weeks) of study	No
Secondary	MRI images		begining (0 weeks), middle (6 weeks) and end (12 weeks) of study	No