ECE: The Entorhinal Cortex and Aerobic Exercise in Aging

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT02775760

Collaborator

Brigham and Women's Hospital (Other), Georgia Institute of Technology (Other), National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

36.6

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of this study is to examine how regular exercise affects brain function, spatial memory, and virtual navigation. Participation in this research study will take approximately 4 months.

Condition or Disease	Intervention/Treatment	Phase
Aging	Behavioral: Cardiovascular endurance Behavioral: Strength, balance, and flexibility	N/A

Detailed Description

The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes. Specifically, the investigators are examining if exercise improves brain function in a brain area known as the entorhinal cortex. Together with the hippocampus this brain area is important for memory formation and spatial navigation. Participation in this research study will take approximately 4 months. During this time, participants will make three initial study visits. The first visit is for informed consent and screening, the second visit is for baseline fitness testing, and the third visit is for cognitive testing and a functional MRI exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a cognitive task. It will take up to approximately three weeks to complete these initial three study visits. Following the three initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: a cardiovascular endurance-training program (aerobic exercise) and a strength, balance, and flexibility training program (non-aerobic exercise). 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 two follow-up study visits. The first follow-up visit is for fitness testing. The second follow-up visit is for cognitive testing and an MRI exam.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Entorhinal Cortex and Aerobic Exercise in Aging

Actual Study Start Date :

Jan 22, 2018

Actual Primary Completion Date :

Feb 9, 2021

Actual Study Completion Date :

Feb 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiovascular endurance Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity	Behavioral: Cardiovascular endurance Physical exercise at the Boston University Fitness and Recreation Center
Active Comparator: Strength, balance, and flexibility Participants will undergo Strength, balance, and flexibility training.	Behavioral: Strength, balance, and flexibility Physical exercise at the Boston University Fitness and Recreation Center

Arm

Intervention/Treatment

Experimental: Cardiovascular endurance

Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity

Behavioral: Cardiovascular endurance

Physical exercise at the Boston University Fitness and Recreation Center

Active Comparator: Strength, balance, and flexibility

Participants will undergo Strength, balance, and flexibility training.

Behavioral: Strength, balance, and flexibility

Physical exercise at the Boston University Fitness and Recreation Center

Outcome Measures

Primary Outcome Measures

Functional MRI [12 weeks]
Measurement of blood oxygen level dependent (BOLD) signal (i.e. oxygenation levels in active brain areas) to assess change in functional activity during cognitive task performance
Structural MRI [12 weeks]
Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes
Cognitive test performance: spatial memory [12 weeks]
Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.
Cognitive test performance: virtual navigation [12 weeks]
Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.

Secondary Outcome Measures

Aerobic capacity [12 weeks]
Participants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity.
Muscle strength [12 weeks]
Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength.

Other Outcome Measures

Body composition measurement [12 weeks]
Measurement of lean body mass with bio-electrical impedance analysis (BIA) to estimate baseline-to-follow-up change in lean body mass.
Neuropsychological test score: spatial reasoning [12 weeks]
Participants will perform several neuropsychological tests of spatial reasoning to measure baseline-to-follow-up change in spatial reasoning ability. A composite score will be calculated.
Neuropsychological test score: spatial cognition [12 weeks]
Participants will perform several neuropsychological tests of spatial cognition to measure baseline-to-follow-up change in spatial cognition. A composite score will be calculated.
Neuropsychological test score: verbal memory [12 weeks]
Participants will perform a neuropsychological test of verbal memory to measure baseline-to-follow-up change in verbal memory.
Neuropsychological test score: visuospatial memory [12 weeks]
Participants will perform a neuropsychological test of visuospatial memory to measure baseline-to-follow-up change in memory.
Neuropsychological test score: executive function [12 weeks]
Participants will perform a neuropsychological test of executive function to measure baseline-to-follow-up change in executive function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 60-80 years
Physical inactivity/sedentary status (The American College of Sports Medicine defines a sedentary lifestyle as a lifestyle in which a person is not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months.)
Generally healthy
Living in the greater Boston area
Fluent in English (must have attended elementary school and higher in English)
Non-smoking

Exclusion Criteria:

Poor vision that cannot be corrected with glasses or contact lenses
Presence of an acute infection
Diagnosis of kidney failure
Diagnosis of liver disease
Diagnosis of thyrotoxicosis/hyperthyroidism
Diagnosis of cancer
Diagnosis of severe anemia
Past or present conditions that affect cognitive functioning:
learning disability
neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
psychiatric disorders or conditions within last 5 years (depression, anxiety disorder, etc.)
Severe stress
Evidence of cognitive impairment (e.g. dementia)
Claustrophobia (fear of small, enclosed spaces)
Obesity
Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:
heart conditions (e.g. heart attack, arrhythmias, etc.)
circulatory conditions (e.g. uncontrolled hypertension, leg claudication, 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. 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
Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.)
Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.)
Drug abuse or alcohol misuse
Metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, metal implant that is ferrous)
Some known abnormal MRI findings (case by case basis)
Regularly exercising
Unavailable for the approx. 4-month duration of the study