Neuroimaging Study of Exercise and Memory Function

NCT ID: NCT02057354

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-03-31

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Sedentary Young Adults

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

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Healthy Sedentary Older Adults

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

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Endurance Training; Strength, balance, stretching

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Karin Schon

Assisstant Professor, Department of Anatomy & Neurobiology, BUSM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Schon, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33325614 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31588607 (View on PubMed)

Other Identifiers

R00AG036845

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-32635

Identifier Type: -

Identifier Source: org_study_id