The Entorhinal Cortex and Aerobic Exercise in Aging

NCT ID: NCT02775760

Last Updated: 2023-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2021-02-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiovascular endurance

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

Group Type EXPERIMENTAL

Cardiovascular endurance

Intervention Type BEHAVIORAL

Physical exercise at the Boston University Fitness and Recreation Center

Strength, balance, and flexibility

Participants will undergo Strength, balance, and flexibility training.

Group Type ACTIVE_COMPARATOR

Strength, balance, and flexibility

Intervention Type BEHAVIORAL

Physical exercise at the Boston University Fitness and Recreation Center

Interventions

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Cardiovascular endurance

Physical exercise at the Boston University Fitness and Recreation Center

Intervention Type BEHAVIORAL

Strength, balance, and flexibility

Physical exercise at the Boston University Fitness and Recreation Center

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Georgia Institute of Technology

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karin Schon, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://sites.bu.edu/brainplasticity/contact-us/

Brain Plasticity and Neuroimaging Laboratory at Boston University

Other Identifiers

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R21AG049968

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-34579

Identifier Type: -

Identifier Source: org_study_id

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