Cognitive Control and Physical Exercise
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|ClinicalTrials.gov Identifier: NCT01183819|
Recruitment Status : Terminated (insufficient recruitment)
First Posted : August 18, 2010
Last Update Posted : August 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Function Day-to-Day Function||Behavioral: Space Fortress Behavioral: Aerobic Exercise Behavioral: Stretching Behavioral: Control Games||Not Applicable|
Epidemiological evidence suggest that a set of lifetime exposures including educational and occupational attainment and leisure activities later in life are associated with more preserved cognitive and day-to-day functioning and reduced risk of dementia. However, the specific set of activities that can maintain or improve function in late life are relatively unexplored. In the current study, we will test the combined efﬁcacy of two such activities: cognitive training and aerobic exercise. These activities have been shown to increase cognitive function and brain plasticity, respectively. The cognitive intervention that we will use is training with the Space Fortress task. This task is aimed at improving cognitive control processes that underlie multiple activities and are particularly affected by aging. We hypothesize that combining these two interventions will produce synergistic effects that will signiﬁcantly improve cognitive and day-to-day function in healthy older adults.
A total of 90 cognitively-healthy older adults will be recruited and randomly assigned to one of three conditions: control video game, control exercise and combined exercise and space fortress training. A range of cognitive and day-to-day functioning will be assessed at baseline and after three months of training. We will also assess compliance with a home-based version of the training program from the end of the 3-month laboratory-based training and the effect of this compliance on measures of cognition and day-to-day functioning. We hypothesize that the interventions can be sustained over a 1-year period and that larger beneﬁts will be observed in participants that adhere to the protocol.
We also propose two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- we will use a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition. 2) important correlates -- we will explore the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Cognitive Control and Physical Exercise: A Multi-Modal Intervention|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Space Fortress and Exercise
Participants engage in aerobic exercise 4 times week and Space Fortress sessions 3 times a week for a total of 12 weeks.
Behavioral: Space Fortress
Space Fortress sessions 3 times a week for 12 weeksBehavioral: Aerobic Exercise
Aerobic Exercise 4 times a week for 12 weeks
Active Comparator: Control Games and Exercise
Participants engage in aerobic exercise 4 times a week and control game sessions 3 times a week for a total of 12 weeks.
Behavioral: Aerobic Exercise
Aerobic Exercise 4 times a week for 12 weeksBehavioral: Control Games
Control games session 3 times a week for 12 weeks
Active Comparator: Control Games and Stretching
Participants engage in stretching/toning exercises 4 times a week and control game sessions 3 times a week for a total of 12 weeks.
Stretching/Toning exercise 4 times a week for 12 weeks.Behavioral: Control Games
Control games session 3 times a week for 12 weeks
- Changes in measures of executive control function and episodic memory at 6 months [ Time Frame: Baseline and 12 weeks ]tests of global intelligence, executive function, working memory and processing speed
- Changes in brain structure, resting cerebral blood flow and network efficiency at 6 months [ Time Frame: Baseline and 12 weeks ]structural MRI (for gray matter density), resting CBF (arterial spin labeling) and cognitive activation fMRI studies
- Change in aerobic capacity at 6 months [ Time Frame: Baseline and 12 weeks ]aerobic capacity as measured by VO2 max
- Changes in measures of executive control function and episodic memory at 1 year [ Time Frame: Baseline and 52 weeks ]tests of global intelligence, executive function, working memory and processing speed
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 ClinicalTrials.gov identifier (NCT number): NCT01183819
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Yaakov Stern, Ph.D.||Sergievsky Center Columbia University Medical Center|
|Principal Investigator:||Richard Sloan, Ph.D.||Behavioral Medicine Columbia University Medical Center|