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The Entorhinal Cortex and Aerobic Exercise in Aging (ECE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02775760
Recruitment Status : Suspended (Currently suspended due to Covid-19 policies.)
First Posted : May 18, 2016
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
Georgia Institute of Technology
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Boston University

Brief Summary:
The overall goal of this study is to examine how regular exercise affects brain function, spatial memory, and virtual navigation. Participation in this research study will take approximately 4 months.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Cardiovascular endurance Behavioral: Strength, balance, and flexibility Not Applicable

Detailed Description:
The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes. Specifically, the investigators are examining if exercise improves brain function in a brain area known as the entorhinal cortex. Together with the hippocampus this brain area is important for memory formation and spatial navigation. Participation in this research study will take approximately 4 months. During this time, participants will make three initial study visits. The first visit is for informed consent and screening, the second visit is for baseline fitness testing, and the third visit is for cognitive testing and a functional MRI exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a cognitive task. It will take up to approximately three weeks to complete these initial three study visits. Following the three initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: a cardiovascular endurance-training program (aerobic exercise) and a strength, balance, and flexibility training program (non-aerobic exercise). The exercise training program will last 12 weeks. There will be three one-hour exercise sessions per week. After completion of the exercise-training program, participants will attend two follow-up study visits. The first follow-up visit is for fitness testing. The second follow-up visit is for cognitive testing and an MRI exam.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Entorhinal Cortex and Aerobic Exercise in Aging
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiovascular endurance
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Behavioral: Cardiovascular endurance
Physical exercise at the Boston University Fitness and Recreation Center

Active Comparator: Strength, balance, and flexibility
Participants will undergo Strength, balance, and flexibility training.
Behavioral: Strength, balance, and flexibility
Physical exercise at the Boston University Fitness and Recreation Center




Primary Outcome Measures :
  1. Functional MRI [ Time Frame: 12 weeks ]
    Measurement of blood oxygen level dependent (BOLD) signal (i.e. oxygenation levels in active brain areas) to assess change in functional activity during cognitive task performance

  2. Structural MRI [ Time Frame: 12 weeks ]
    Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes

  3. Cognitive test performance: spatial memory [ Time Frame: 12 weeks ]
    Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.

  4. Cognitive test performance: virtual navigation [ Time Frame: 12 weeks ]
    Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.


Secondary Outcome Measures :
  1. Aerobic capacity [ Time Frame: 12 weeks ]
    Participants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity.

  2. Muscle strength [ Time Frame: 12 weeks ]
    Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength.


Other Outcome Measures:
  1. Body composition measurement [ Time Frame: 12 weeks ]
    Measurement of lean body mass with bio-electrical impedance analysis (BIA) to estimate baseline-to-follow-up change in lean body mass.

  2. Neuropsychological test score: spatial reasoning [ Time Frame: 12 weeks ]
    Participants will perform several neuropsychological tests of spatial reasoning to measure baseline-to-follow-up change in spatial reasoning ability. A composite score will be calculated.

  3. Neuropsychological test score: spatial cognition [ Time Frame: 12 weeks ]
    Participants will perform several neuropsychological tests of spatial cognition to measure baseline-to-follow-up change in spatial cognition. A composite score will be calculated.

  4. Neuropsychological test score: verbal memory [ Time Frame: 12 weeks ]
    Participants will perform a neuropsychological test of verbal memory to measure baseline-to-follow-up change in verbal memory.

  5. Neuropsychological test score: visuospatial memory [ Time Frame: 12 weeks ]
    Participants will perform a neuropsychological test of visuospatial memory to measure baseline-to-follow-up change in memory.

  6. Neuropsychological test score: executive function [ Time Frame: 12 weeks ]
    Participants will perform a neuropsychological test of executive function to measure baseline-to-follow-up change in executive function.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 60-80 years
  • Physical inactivity/sedentary status (The American College of Sports Medicine defines a sedentary lifestyle as a lifestyle in which a person is not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months.)
  • Generally healthy
  • Living in the greater Boston area
  • Fluent in English (must have attended elementary school and higher in English)
  • Non-smoking

Exclusion Criteria:

  • Poor vision that cannot be corrected with glasses or contact lenses
  • Presence of an acute infection
  • Diagnosis of kidney failure
  • Diagnosis of liver disease
  • Diagnosis of thyrotoxicosis/hyperthyroidism
  • Diagnosis of cancer
  • Diagnosis of severe anemia
  • Past or present conditions that affect cognitive functioning:

    • learning disability
    • neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
    • psychiatric disorders or conditions within last 5 years (depression, anxiety disorder, etc.)
    • Severe stress
  • Evidence of cognitive impairment (e.g. dementia)
  • Claustrophobia (fear of small, enclosed spaces)
  • Obesity
  • Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:

    • heart conditions (e.g. heart attack, arrhythmias, etc.)
    • circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)
    • respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
    • current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
    • diagnosis of electrolyte disorder or abnormality
    • presence of diabetes mellitus
  • Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.)
  • Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.)
  • Drug abuse or alcohol misuse
  • Metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, metal implant that is ferrous)
  • Some known abnormal MRI findings (case by case basis)
  • Regularly exercising
  • Unavailable for the approx. 4-month duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775760


Locations
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United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Brigham and Women's Hospital
Georgia Institute of Technology
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Karin Schon, Ph.D. Boston University
Additional Information:
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02775760    
Other Study ID Numbers: H-34579
R21AG049968 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
brain
brain mapping
cognition
exercise
physical activity
hippocampus
entorhinal cortex
spatial navigation
learning
memory
magnetic resonance imaging
functional neuroimaging
physical endurance
physical fitness
resistance training
walking
muscle stretching exercises
exercise test
neuropsychological tests
executive function
attention
body composition