Clinical trial NCT02057354: Neuroimaging Study of Exercise and Memory Function
Official title: Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Brain
Brain-Derived Neurotrophic Factor
Brain Mapping
Cognition
Exercise
Hippocampus
Hydrocortisone
Learning
Memory
Magnetic Resonance Imaging
Nerve Growth Factors
Neuroimaging
Physical Endurance
Physical Fitness
Resistance Training
Walking
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-02-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: MRI
timeFrame: 1.5 to 2 hours each at Visits 4 and 43
measure: Serum BDNF level
timeFrame: 5 minutes each at Visits 4 and 43
measure: Memory test performance
timeFrame: 1.5 to 2 hours each at Visits 4 and 43
Secondary outcomes:
measure: Aerobic capacity and muscle strength
timeFrame: 80 min each at Visits 2, 3, 41 and 42
Other outcomes:
measure: Blood cortisol levels
timeFrame: 5 min each at Visits 4 and 43
measure: Anthropometric measurements
timeFrame: 10 minutes each during Visits 2 and 41
measure: Blood serum levels of other neurotrophins
timeFrame: 5 min each at Visit 4 and 43
measure: Neuropsychological test performance
timeFrame: 15-30 minutes each at Visits 4 and 43
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Karin Schon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kern KL, Storer TW, Schon K. Cardiorespiratory fitness, hippocampal subfield volumes, and mnemonic discrimination task performance in aging. Hum Brain Mapp. 2021 Mar;42(4):871-892. doi: 10.1002/hbm.25259. Epub 2020 Dec 16.
citation: 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. 2020 May;30(5):488-504. doi: 10.1002/hipo.23166. Epub 2019 Oct 7.