Neuroimaging Study of Exercise and Memory Function

Aging Clinical Trial

— EMF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057354
• Other study ID #: H-32635
• Secondary ID: R00AG036845
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: April 23, 2018
• Start date: April 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood cortisol levels	Cortisol levels will be obtained from the blood sample drawn during baseline and follow-up.	5 min each at Visits 4 and 43
Other	Anthropometric measurements	Anthropometric measurements include height, weight, and body mass index. Percent body fat will also be estimated.	10 minutes each during Visits 2 and 41
Other	Blood serum levels of other neurotrophins	The blood draw will be used for other neurotrophins related to exercise and cognition.	5 min each at Visit 4 and 43
Other	Neuropsychological test performance	Baseline-to-follow-up change in performance of the Wechsler Adult Intelligence Scale-IV subtests	15-30 minutes each at Visits 4 and 43
Primary	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
Primary	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
Primary	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	Aerobic capacity and muscle strength	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.	80 min each at Visits 2, 3, 41 and 42