Trial record 1 of 2 for:    Yaakov Stern AND Richard Sloan
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Cognitive Control and Physical Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yaakov Stern, Columbia University
ClinicalTrials.gov Identifier:
NCT01183819
First received: August 16, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: February 2014 (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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 60-75
  2. English-speaking
  3. Strongly right-handed
  4. BMI > 18.5 and < 32
  5. Post-menopausal (women only): no estrogen replacement therapy
  6. 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:

  1. MRI contraindications (e.g., metallic implants, pacemaker, weight > 350 lbs, waist > 55")
  2. Hearing impaired/hearing aids, unable to read newspaper at arm's length with corrective lenses
  3. Objective cognitive impairment
  4. Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing
  5. Cardiovascular disease
  6. Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures)
  7. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma
  8. 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).
  9. HIV infection
  10. Pregnant or lactating (participation allowed 3 months after ceasing lactation
  11. Other medical disorders judge to interfere with study
  12. Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month
  13. Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies
  14. Any history of psychosis or electroconvulsive therapy
  15. Psychotic disorder (lifetime)
  16. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  17. Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation
  18. 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
  19. Diagnosed learning disability, dyslexia
  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: NCT01183819

Contacts
Contact: Dierdre M O'Shea, MA 212-305-5933 dmo2123@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Leigh Rich, BA    212-305-0436    lr2453@columbia.edu   
Principal Investigator: Yaakov Stern, Ph.D.         
Principal Investigator: Richard Sloan, Ph.D.         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Yaakov Stern, Ph.D. Sergievsky Center Columbia University Medical Center
Principal Investigator: Richard Sloan, Ph.D. Behavioral Medicine Columbia University Medical Center
  More Information

No publications provided

Responsible Party: Yaakov Stern, Professor of Clinical, Columbia University
ClinicalTrials.gov Identifier: NCT01183819     History of Changes
Other Study ID Numbers: AAAE5848, R01AG034178
Study First Received: August 16, 2010
Last Updated: September 23, 2013
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 19, 2014