Trial record 2 of 2 for:    Yaakov Stern AND Richard Sloan

Cognitive Benefits of Aerobic Exercise Across the Age Span

This study is currently recruiting participants.
Verified December 2012 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01179958
First received: August 10, 2010
Last updated: October 23, 2013
Last verified: December 2012

August 10, 2010
October 23, 2013
August 2010
August 2015   (final data collection date for primary outcome measure)
Change from baseline in measures of executive control function and episodic memory at 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
tests of global intelligence, executive function, working memory and processing speed
Changes in measures of executive control function and episodic memory at 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
tests of global intelligence, executive function, working memory and processing speed
Complete list of historical versions of study NCT01179958 on ClinicalTrials.gov Archive Site
  • Change from baseline in brain structure, resting cerebral blood flow and network efficiency at 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    structural MRI (for gray matter density), resting CBF (arterial spin labeling) and cognitive activation fMRI studies
  • Change from baseline in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in aerobic capacity at 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    aerobic capacity as measured by VO2 max
  • Change from baseline in measures of executive control function and episodic memory at 1 year [ Time Frame: 48 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: 24 weeks ] [ Designated as safety issue: No ]
    structural MRI (for gray matter density), resting CBF (arterial spin labeling) and cognitive activation fMRI studies
  • Changes in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in aerobic capacity at 6 months [ Time Frame: 24 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: 48 weeks ] [ Designated as safety issue: No ]
    tests of global intelligence, executive function, working memory and processing speed
Not Provided
Not Provided
 
Cognitive Benefits of Aerobic Exercise Across the Age Span
Cognitive Benefits of Aerobic Exercise Across the Age Span

The purpose of this study is to test the hypothesis that aerobic exercise leads improved cognitive function accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation.

While animal and human studies indicate cognitive benefits from aerobic exercise across the lifespan, the great majority of controlled exercise studies in humans have been restricted to elderly individuals. Those studies have indicated that enhancing aerobic capacity has a beneficial effect on cognition. One study suggests that this benefit is seen particularly for executive control processes, precisely the processes affected by aging. These improvements have been accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation. The goal of the proposed study is to extend the investigation of the beneficial effects of aerobic exercise to younger individuals, and to compare these effects in young and old.

In this application we propose to conduct a study in which 260 sedentary but otherwise healthy and cognitively intact individuals in 2 age groups, young (25-40) and younger old (50-65), are randomized to two training conditions, aerobic exercise and stretching/toning, to be completed at The Plus One Fitness Center at Columbia University. Subjects will be assessed for aerobic capacity, cognitive task performance, and by structural MRI, resting cerebral blood flow scans (arterial spin labeling) and cognitive activation fMRI studies at study entry and after 6 months of training.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Cognitive Function
  • Behavioral: aerobic training
    24 weeks of aerobic training, 4X/week
    Other Name: Training, aerobic
  • Behavioral: stretching/toning
    stretches and toning exercises designed to promote flexibility and improved core strength
    Other Name: Exercises, stretches and toning
  • Experimental: aerobic training
    24 weeks of aerobic training, 4X/week
    Intervention: Behavioral: aerobic training
  • Placebo Comparator: stretching/toning
    stretching/toning condition, 24 weeks to parallel the active intervention group
    Intervention: Behavioral: stretching/toning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 20-45, 50-65
  2. English-speaking
  3. strongly right-handed
  4. BMI > 18.5 and < 32
  5. Pre-menopausal (women only): no oral contraceptive use Post-menopausal: no estrogen replacement therapy
  6. sedentary: VO2max < 43 and 36 ml/kg/min for men age 25-40 and 50-65, respectively; < 36 and 29 ml/kg/min for women age 25-40 and 50-65 respectively

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. Medications that target CNS (e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month
  12. Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies
  13. Any history of psychosis or electroconvulsive therapy
  14. Psychotic disorder (lifetime)
  15. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  16. Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation
  17. 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
  18. Diagnosed learning disability, dyslexia
Both
20 Years to 65 Years
Yes
Contact: Richard P Sloan, PhD 212-851-5575 rps7@columbia.edu
United States
 
NCT01179958
6211, AG030092
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
Not Provided
Principal Investigator: Richard P Sloan, PhD Columbia University
Principal Investigator: Yaakov Stern, PhD Columbia University
New York State Psychiatric Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP