Cognitive Benefits of Aerobic Exercise Across the Age Span

August 15, 2018 updated by: Richard Sloan, New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Richard Sloan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: aerobic training
24 weeks of aerobic training, 4 times/week
Behavioral: aerobic training
24 weeks of aerobic training, 4X/week
Other Names:
  • 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 Names:
  • Exercises, stretches and toning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in measures of executive control function and episodic memory at 6 months
Time Frame: 24 weeks
tests of global intelligence, executive function, working memory and processing speed
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in brain structure, resting cerebral blood flow and network efficiency at 6 months
Time Frame: 24 weeks
structural MRI (for gray matter density), resting CBF (cerebral blood flow, measured by arterial spin labeling) and cognitive activation fMRI studies
24 weeks
Change from baseline in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Change from baseline in aerobic capacity at 6 months
Time Frame: 24 weeks
aerobic capacity as measured by VO2 max
24 weeks
Change from baseline in measures of executive control function and episodic memory at 1 year
Time Frame: 48 weeks
tests of global intelligence, executive function, working memory and processing speed
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

June 29, 2016

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #6211/7140R
  • AG030092 (OTHER: CU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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