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Completed

NCT Number: NCT02057354

Neuroimaging Study of Exercise and Memory Function

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.

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Key information

Conditions

Aging Behavior Motor Activity

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • learning disability
  • neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
  • 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:
  • heart (e.g. heart attack, arrhythmias, etc.)
  • circulatory (e.g. uncontrolled hypertension, 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. leg claudication, 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
  • 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

Treatment and study plan

Aerobic Exercise

Behavioral

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

Non-Aerobic Exercise

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: EMF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2014
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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