Suspended

ECEThe Entorhinal Cortex and Aerobic Exercise in Aging

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What is being tested

Cardiovascular endurance

+ Strength, balance, and flexibility

Behavioral
Who is being recruted

Behavior+1

+ Motor Activity

+ Spatial Behavior

From 60 to 80 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorBoston University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 22, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleThe Entorhinal Cortex and Aerobic Exercise in Aging
NCT02775760
Principal SponsorBoston University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMotor ActivitySpatial BehaviorSpatial Navigation

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
Participants will undergo Strength, balance, and flexibility training.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Boston University School of Medicine

Boston, United StatesOpen Boston University School of Medicine in Google Maps
SuspendedOne Study Center