Cognitive Control and Physical Exercise
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The purpose of this study is to test the hypothesis that aerobic exercise and a computer-based cognitive intervention leads to improved cognitive function accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation.
Condition | Intervention |
---|---|
Cognitive Function Day-to-Day Function |
Behavioral: Space Fortress Behavioral: Aerobic Exercise Behavioral: Stretching Behavioral: Control Games |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
Official Title: | Cognitive Control and Physical Exercise: A Multi-Modal Intervention |
- Changes in measures of executive control function and episodic memory at 6 months [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]tests of global intelligence, executive function, working memory and processing speed
Estimated Enrollment: | 90 |
Study Start Date: | February 2010 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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 weeks
Behavioral: 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 weeks
Behavioral: 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.
|
Behavioral: Stretching
Stretching/Toning exercise 4 times a week for 12 weeks.
Behavioral: Control Games
Control games session 3 times a week for 12 weeks
|
Detailed Description:
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.
Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 60-75
- English-speaking
- Strongly right-handed
- BMI > 18.5 and < 32
- Post-menopausal (women only): no estrogen replacement therapy
- Sedentary: VO2max < 36 ml/kg/min for men age 60-75; < 29 ml/kg/min for women age 60-75 (determined using Jones Formula Men = (60-(0.55*AGE)) Women = (48-(.37*AGE))
Exclusion Criteria:
- MRI contraindications (e.g., metallic implants, pacemaker, weight > 350 lbs, waist > 55")
- Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective lenses
- Objective cognitive impairment
- Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing
- Cardiovascular disease
- Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures)
- Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma
- Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II).
- HIV infection
- Pregnant or lactating (participation allowed 3 months after ceasing lactation
- Other medical disorders judge to interfere with study
- Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month
- Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies
- Any history of psychosis or electroconvulsive therapy
- Psychotic disorder (lifetime)
- Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
- Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation
- Imaged cortical stroke or large subcortical lacunae or infarct or space-occupying lesion (≥ 2 cubic cm). Other findings, e.g., periventricular caps or small white matter hyperintensities, do not result in exclusion
- Diagnosed learning disability, dyslexia
Contact: Joel Villanueva | 212-851-5593 | jjv2112@columbia.edu |
Contact: Leigh Rich, BA | 212-305-0436 | lr2453@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Joel Villanueva 212-851-5593 jjv2112@columbia.edu | |
Contact: Leigh Rich, BA 212-305-0436 lr2453@columbia.edu | |
Principal Investigator: Yaakov Stern, Ph.D. | |
Principal Investigator: Richard Sloan, Ph.D. |
Principal Investigator: | Yaakov Stern, Ph.D. | Sergievsky Center Columbia University Medical Center |
Principal Investigator: | Richard Sloan, Ph.D. | Behavioral Medicine Columbia University Medical Center |
No publications provided
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT01183819 History of Changes |
Other Study ID Numbers: | AAAE5848, R01AG034178 |
Study First Received: | August 16, 2010 |
Last Updated: | January 11, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
cognitive function fMRI apoE inflammatory markers |
exercise cognitive intervention Space Fortress |
ClinicalTrials.gov processed this record on October 17, 2012