Neuroimaging Study of Exercise and Memory Function
EMF
Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure
2 other identifiers
interventional
190
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 25, 2018
April 1, 2018
3.8 years
February 5, 2014
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
MRI
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
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
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 Outcomes (1)
Aerobic capacity and muscle strength
80 min each at Visits 2, 3, 41 and 42
Other Outcomes (4)
Blood cortisol levels
5 min each at Visits 4 and 43
Anthropometric measurements
10 minutes each during Visits 2 and 41
Blood serum levels of other neurotrophins
5 min each at Visit 4 and 43
- +1 more other outcomes
Study Arms (2)
Healthy Sedentary Young Adults
ACTIVE COMPARATORParticipants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.
Healthy Sedentary Older Adults
EXPERIMENTALParticipants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Non-smoking
- Age between 18-35 years or between 55-85 years
- Sedentary status (physically inactive)
- Generally healthy
- Native-English speaker
You may not qualify if:
- 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.)
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Related Publications (2)
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.
PMID: 33325614DERIVEDNauer 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.
PMID: 31588607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Schon, PhD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor, Department of Anatomy & Neurobiology, BUSM
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 7, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2018
Study Completion
March 1, 2018
Last Updated
April 25, 2018
Record last verified: 2018-04