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Cognitive Benefits of Aerobic Exercise Across the Age Span

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01179958
First received: August 10, 2010
Last updated: October 5, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention
Cognitive Function
Behavioral: aerobic training
Behavioral: stretching/toning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cognitive Benefits of Aerobic Exercise Across the Age Span

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 (cerebral blood flow, measured by 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


Estimated Enrollment: 260
Study Start Date: August 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aerobic training
24 weeks of aerobic training, 4 times/week
Behavioral: aerobic training
24 weeks of aerobic training, 4X/week
Other Name: Training, aerobic
Placebo Comparator: stretching/toning
stretching/toning condition, 24 weeks to parallel the active intervention group
Behavioral: stretching/toning
stretches and toning exercises designed to promote flexibility and improved core strength
Other Name: Exercises, stretches and toning

Detailed Description:

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 the study team propose to conduct a study in which 270 sedentary but otherwise healthy and cognitively intact individuals in the 20-68 year age range are randomized to two training conditions, aerobic exercise and stretching/toning, to be completed at YMCAs and YMHAs in New York City. Participants 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.

The study also proposes two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition will be used. 2) important correlates -- the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise will be explored.

  Eligibility

Ages Eligible for Study:   20 Years to 68 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 20-68
  2. English-speaking
  3. strongly right-handed
  4. BMI < 35
  5. Pre-menopausal (women only): no oral contraceptive use Post-menopausal: no estrogen replacement therapy
  6. sedentary: VO2 max < 41 and 31.6 ml/kg/min for men age 20-40 and 50-68 and < 35.2 and 26.6 ml/kg/min for women age 20-40 and 50-68 respectively
  7. participants over age 60 must have ECG within past 3 months

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 ≥ 140 mmHg; or diastolic blood pressure ≥ 90 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 (central nervous system, 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
  19. Current or recent (Past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety Disorder
  20. Dementia Rating Scale < 135
  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: NCT01179958

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Richard P Sloan, PhD Columbia University
Principal Investigator: Yaakov Stern, PhD Columbia University
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01179958     History of Changes
Other Study ID Numbers: #6211/7140R  AG030092 
Study First Received: August 10, 2010
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
cognitive function
fMRI
apoE
inflammatory markers
exercise

ClinicalTrials.gov processed this record on September 30, 2016