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Clinical Trials/NCT02057354
NCT02057354CompletedNot Applicable

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

Boston University2 sites in 1 country190 target enrollmentStarted: April 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
2
Primary Endpoint
MRI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • 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

Arms & Interventions

Healthy Sedentary Young Adults

Active Comparator

Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.

Intervention: Aerobic Exercise (Behavioral)

Healthy Sedentary Young Adults

Active Comparator

Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.

Intervention: Non-Aerobic Exercise (Behavioral)

Healthy Sedentary Older Adults

Experimental

Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.

Intervention: Aerobic Exercise (Behavioral)

Healthy Sedentary Older Adults

Experimental

Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.

Intervention: Non-Aerobic Exercise (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Aerobic capacity and muscle strength(80 min each at Visits 2, 3, 41 and 42)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karin Schon

Assisstant Professor, Department of Anatomy & Neurobiology, BUSM

Boston University

Study Sites (2)

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