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Trial record 1 of 1 for:    Exercise, Age-Related Memory Decline, and Hippocampal Function
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Exercise, Age-Related Memory Decline, And Hippocampal Function

This study is currently recruiting participants.
Verified March 2012 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01329653
First received: July 28, 2010
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to test the hypothesis that aerobic exercise leads increased cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older adults.


Condition Intervention
Cognitive Deterioration
Disorder of Aging
 Behavioral: aerobic training
Behavioral: Wait list

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise, Age-Related Memory Decline, And Hippocampal Function

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • dentate gyrus cerebral blood volume [ Time Frame: change from before (pre) to after (post) 12 weeks of training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive function [ Time Frame: change from before (pre) to after (post) 12 weeks of training ] [ Designated as safety issue: No ]
    measures of memory, executive function, attention/processing speed, language, and general intelligence

  • aerobic capacity [ Time Frame: change from before (pre) to after (post) 12 weeks of training ] [ Designated as safety issue: No ]
  • cerebral blood flow [ Time Frame: change from before (pre) to after (post) 12 weeks of training ] [ Designated as safety issue: No ]
    arterial spin labeling fMRI


Estimated Enrollment: 182
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aerobic training
12 weeks of aerobic training, 4X/week
 Behavioral: aerobic training
12 weeks of aerobic training, 4X/week
Other Name: Aerobic training
Placebo Comparator: wait list control
wait list control condition, 12 weeks to parallel the active intervention group
 Behavioral: Wait list
wait list control condition
Other Name: Wait list control

Detailed Description:

In the US, increased length of life and reduced morbidity and mortality have resulted in a growing number of older adults, the demographic "time bomb" often referred to in discussions of public policy. According to the Census Bureau, the population aged 65 and over will double in size within the next 25 years. Moreover, these older adults will live healthier lives than their predecessors. While this increased length of a healthy life is an undeniable societal benefit, it brings with it a major societal problem: an epidemic of aging-related cognitive decline. The need to develop interventions to address this growing problem is urgent. Aging-related cognitive dysfunction is not diffuse; rather it targets selected brain areas, in particular the frontal lobes and the hippocampal formation. The separate but interconnected subregions of the hippocampus are differentially vulnerable to pathogenic mechanisms, including the normal aging process. A range of in vivo and post-mortem studies have converged on the dentate gyrus (DG) as the hippocampal subregion differentially targeted by the aging process. As with pathogenic processes, any intervention that improves brain function does so with regional selectivity. One such intervention is physical exercise, which has been shown to improve both frontal lobe and hippocampal function. Using a high-resolution variant of functional magnetic resonance imaging (fMRI), the investigators have demonstrated that aerobic training selectively benefitted DG function both humans and mice. In addition, improvement in DG function was associated with improved performance on a word list learning task but not in tasks conventionally thought to be frontal lobe dependent. The human part of the study had significant shortcomings, however: it was small (N = 11), lacked a control group, enrolled only young subjects (age 20-45 years), and employed only a limited neuropsychological testing battery. The overall goal of this proposal is to use the high-resolution variant of fMRI to test the hypothesis that aerobic training will induce improvements in DG function in a sample of younger (age 20-35) and older (50-65) adults, assigned randomly to an active training condition or wait list control group. The investigators will use more comprehensive neuropsychological testing to examine the relationship between changes in DG function and selected cognitive capacities. Taken together with the observation that normal aging differentially targets the DG, this research program will establish that physical exercise is an effective approach for ameliorating the insidious cognitive slide that occurs in aging. Thus, the potential significance of this application is substantial.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 20-35 years, and 50-65 years
  2. English-speaking
  3. Ambulatory Interview
  4. "Average" fitness as determined by AHA standards (VO2max < 43 and 36 ml/kg/min for men age 20-35 years and 50-65 years, respectively; < 36 and 29 ml/kg/min for women age 20-35 years and 50-65 years respectively)

Exclusion Criteria:

  1. Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing
  2. Cardiovascular disease
  3. Uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg; or diastolic blood pressure ≥ 105 mmHg on two measures)
  4. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion.
  5. 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). Well-treated hypothyroidism will not be excluded.
  6. HIV infection
  7. Pregnant or lactating (participation allowed 3 months after ceasing lactation).
  8. Medications that alter inflammation or autonomic nervous system activity
  9. Any history of psychosis or ECT
  10. Psychotic disorder (lifetime)
  11. Current or recent (past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety disorder
  12. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  13. Dietary supplements that affect inflammation or the ANS
  14. Cardiac Pacemaker
  15. Internal Pump
  16. Insulin Pump
  17. Tattoo eyeliner
  18. Wire Sutures
  19. Internal Metal Objects
  20. Metal Slivers in Eye
  21. Prosthesis
  22. Hearing Aid Implants
  23. Neurostimulator
  24. Metal Fragments
  25. Brain Aneurysm Clips
  26. Vascular Clips
  27. Breast Expander
  28. Vena Cava Filter
  29. Heart Valve
  30. Metal Stents
  31. Asthma
  32. Hay-Fever
  33. Sickle Cell Disease
  34. Kidney Disease
  35. Pregnant
  36. Machinist or ever worked with heavy metals
  37. Contraindication to gadolinium, including prior adverse reaction to gadolinium, past or current history of severe breathing difficulty that has been treated by a physician (e.g., asthma, COPD, etc.), and sickle cell disease. History of renal impairment or estimated glomerular filtration rate <30 L/min/1.73m2 is also exclusionary.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329653

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Richard P Sloan, PhD     212-851-5575     rps7@columbia.edu    
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Richard P Sloan, PhD Columbia University
  More Information

Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01329653     History of Changes
Other Study ID Numbers: 6219, AG035015
Study First Received: July 28, 2010
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
cerebral blood volume
aging
exercise

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013