Neuroimaging Study of Exercise and Memory Function (EMF)

April 23, 2018 updated by: Karin Schon, Boston University

Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy Sedentary Young Adults
Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.
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 Names:
  • 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 Names:
  • Strength, balance, stretching
Experimental: Healthy Sedentary Older Adults
Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.
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 Names:
  • 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 Names:
  • Strength, balance, stretching

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1.5 to 2 hours each at Visits 4 and 43
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
5 minutes each at Visits 4 and 43
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.
1.5 to 2 hours each at Visits 4 and 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
80 min each at Visits 2, 3, 41 and 42

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 min each at Visits 4 and 43
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.
10 minutes each during Visits 2 and 41
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.
5 min each at Visit 4 and 43
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
15-30 minutes each at Visits 4 and 43

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karin Schon, PhD, Boston University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-32635
  • R00AG036845 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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