EMF: Neuroimaging Study of Exercise and Memory Function

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT02057354

Collaborator

National Institute on Aging (NIA) (NIH)

190

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Behavioral: Aerobic Exercise Behavioral: Non-Aerobic Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Other Names:

Strength, balance, stretching

Outcome Measures

Primary Outcome Measures

MRI [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 [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 [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 Outcome Measures

Aerobic capacity and muscle strength [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 Outcome Measures

Blood cortisol levels [5 min each at Visits 4 and 43]
Cortisol levels will be obtained from the blood sample drawn during baseline and follow-up.
Anthropometric measurements [10 minutes each during Visits 2 and 41]
Anthropometric measurements include height, weight, and body mass index. Percent body fat will also be estimated.
Blood serum levels of other neurotrophins [5 min each at Visit 4 and 43]
The blood draw will be used for other neurotrophins related to exercise and cognition.
Neuropsychological test performance [15-30 minutes each at Visits 4 and 43]
Baseline-to-follow-up change in performance of the Wechsler Adult Intelligence Scale-IV subtests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

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
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