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Neuroimaging Study of Exercise and Memory Function (EMF)

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: NCT02057354
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Karin Schon, Boston University

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date April 25, 2018
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • MRI [ Time Frame: 1.5 to 2 hours each at Visits 4 and 43 ]
    Measurement of brain activity during task performance and measurement of change in regional brain volumes.
  • Serum BDNF level [ Time Frame: 5 minutes each at Visits 4 and 43 ]
    Fasting blood draw on same day of MRI to measure change in serum BDNF from baseline to follow-up
  • Memory test performance [ Time Frame: 1.5 to 2 hours each at Visits 4 and 43 ]
    Participants will perform recognition memory tests during and after functional MRI. Measurements include baseline-to-follow-up change in reaction times and accuracy.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • MRI [ Time Frame: 1.5 to 2 hours each at Visits 3 and 41 ]
    Measurement of BOLD signal to assess change in functional activity during task performance and to measure change in regional brain volumes.
  • Serum BDNF level [ Time Frame: 5 minutes each at Visits 3 and 41 ]
    Fasting blood draw on same day of MRI to measure change in serum BDNF from baseline to follow-up
  • Memory test performance [ Time Frame: 1.5 to 2 hours each at Visits 3 and 41 ]
    Participants will perform recognition memory tests during and after functional MRI. Measurements include baseline-to-follow-up change in reaction times and accuracy.
Change History Complete list of historical versions of study NCT02057354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
Aerobic capacity and muscle strength [ Time Frame: 80 min each at Visits 2, 3, 41 and 42 ]
Participants will perform two treadmill tests and several muscle strength tests to estimate baseline-to-follow-up change in aerobic capacity, measure change in time on treadmill, and determine change in muscle strength.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Aerobic capacity [ Time Frame: 1 hour each at Visits 2 and 40 ]
Participants will perform a submaximal incremental work rate test and a constant work rate test to estimate baseline-to-follow-up change in aerobic capacity and measure change in time on treadmill, respectively.
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2015)
  • Blood cortisol levels [ Time Frame: 5 min each at Visits 4 and 43 ]
    Cortisol levels will be obtained from the blood sample drawn during baseline and follow-up.
  • Anthropometric measurements [ Time Frame: 10 minutes each during Visits 2 and 41 ]
    Anthropometric measurements include height, weight, and body mass index. Percent body fat will also be estimated.
  • Blood serum levels of other neurotrophins [ Time Frame: 5 min each at Visit 4 and 43 ]
    The blood draw will be used for other neurotrophins related to exercise and cognition.
  • Neuropsychological test performance [ Time Frame: 15-30 minutes each at Visits 4 and 43 ]
    Baseline-to-follow-up change in performance of the Wechsler Adult Intelligence Scale-IV subtests
Original Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
  • Blood cortisol levels [ Time Frame: 5 min each at Visits 3 and 41 ]
    Cortisol levels will be obtained from the blood sample drawn during baseline and follow-up.
  • Anthropometric measurements [ Time Frame: 10 minutes each during Visits 2 and 40 ]
    Anthropometric measurements include height, weight, and body mass index. Percent body fat will also be estimated.
  • Blood serum levels of other neurotrophins [ Time Frame: 5 min each at Visit 3 and 41 ]
    The blood draw will be used for other neurotrophins related to exercise and cognition.
  • Neuropsychological test performance [ Time Frame: 10-30 minutes each at Visits 3 and 41 ]
    Baseline-to-follow-up change in performance of the Wechsler Adult Intelligence Scale-IV subtests
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Study of Exercise and Memory Function
Official Title  ICMJE Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure
Brief Summary The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes, brain function, and the amount of several proteins in the blood. These proteins include a hormone called cortisol, also known as the "stress hormone," and a growth factor called "brain-derived neurotrophic factor" (BDNF). The "stress hormone" cortisol is produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and in the body. It plays a role in the growth, maturation, and maintenance of these cells. The amount of this protein in blood samples is therefore an indicator of healthy nerve cell function. Here, the investigators are investigating if exercise improves brain function by changing BDNF levels. Participation in this research study will take approximately 4 months. During this time, participants will make four initial study visits. The first visit is for informed consent and screening, the second and third visits are for baseline fitness testing, and the fourth visit is for a blood draw, cognitive testing, and a functional Magnetic Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a given task. It will take up to approximately three weeks to complete these initial four study visits. Following the four initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: an aerobic exercise program and a non-aerobic exercise program consisting of strengthening, balance and stretching exercises. 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 three follow-up study visits. The first two follow-up visits are for fitness testing. The third and final follow-up visit is for a blood draw, cognitive testing, and an MRI exam.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Aging
Intervention  ICMJE
  • Behavioral: Aerobic Exercise
    The goal of the aerobic exercise training is to increase aerobic endurance. Walking on treadmill at moderate intensity with grade adjusted. Exercise tailored to individual ability level.
    Other Name: Endurance Training
  • Behavioral: Non-Aerobic Exercise
    The goal of this training is to improve overall muscle strength, balance and flexibility. Participants will do strength, balance and stretching exercises. Exercises tailored to individual ability level.
    Other Name: Strength, balance, stretching
Study Arms  ICMJE
  • Active Comparator: Healthy Sedentary Young Adults
    Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.
    Interventions:
    • Behavioral: Aerobic Exercise
    • Behavioral: Non-Aerobic Exercise
  • Experimental: Healthy Sedentary Older Adults
    Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.
    Interventions:
    • Behavioral: Aerobic Exercise
    • Behavioral: Non-Aerobic Exercise
Publications * Nauer RK, Dunne MF, Stern CE, Storer TW, Schon K. Improving fitness increases dentate gyrus/CA3 volume in the hippocampal head and enhances memory in young adults. Hippocampus. 2019 Oct 7. doi: 10.1002/hipo.23166. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
190
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
80
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-smoking
  • Age between 18-35 years or between 55-85 years
  • Sedentary status (physically inactive)
  • Generally healthy
  • Native-English speaker

Exclusion Criteria:

  • Diagnosis of severe anemia
  • Past or present condition that affect cognitive functioning:

    1. learning disability
    2. neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
    3. psychiatric disorders or conditions (depression, anxiety disorder, etc.)
  • Poor vision that cannot be corrected with glasses or contact lenses
  • Presence of an infection
  • Diagnosis of kidney failure
  • Diagnosis of liver disease
  • Diagnosis of thyrotoxicosis/hyperthyroidism
  • Diagnosis of cancer
  • Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:

    1. heart (e.g. heart attack, arrhythmias, etc.)
    2. circulatory (e.g. uncontrolled hypertension, high cholesterol, etc.)
    3. respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
    4. current musculoskeletal impairments (e.g. leg claudication, fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
    5. diagnosis of electrolyte disorder or abnormality
    6. presence of diabetes mellitus
  • Claustrophobia (fear of small, encloses spaces)
  • Female subjects: breast-feeding or potentially pregnant
  • Obesity
  • Eating disorder
  • Compulsive exercising
  • Ferro-magnetic metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, permanent tattoo or eyeliner with metallic specks)
  • Prescription medication or other drugs that are cardio-active
  • Prescription medication or other drugs that are psycho-active
  • Drug abuse or alcohol misuse
  • Regularly exercising
  • Unavailable for the approximately 4-month duration of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057354
Other Study ID Numbers  ICMJE H-32635
R00AG036845 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karin Schon, Boston University
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Karin Schon, PhD Boston University
PRS Account Boston University
Verification Date April 2018

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