Clinical trial NCT02775760: The Entorhinal Cortex and Aerobic Exercise in Aging
Official title: The Entorhinal Cortex and Aerobic Exercise in Aging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Keywords: brain
brain mapping
cognition
exercise
physical activity
hippocampus
entorhinal cortex
spatial navigation
learning
memory
magnetic resonance imaging
functional neuroimaging
physical endurance
physical fitness
resistance training
walking
muscle stretching exercises
exercise test
neuropsychological tests
executive function
attention
body composition
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Georgia Institute of Technology
name: National Institute on Aging (NIA)
First posted: 2016-05-18
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Functional MRI - Right Subiculum
timeFrame: 0 months-baseline (pre-intervention)
measure: Structural MRI - Right Dentate Gyrus Head
timeFrame: 0 months-baseline (pre-intervention)
measure: Cognitive Test Performance: Spatial Memory
timeFrame: 4 months
measure: Cognitive Test Performance: Virtual Navigation
timeFrame: 4 months
measure: Functional MRI - Post-intervention Right Subiculum
timeFrame: 4 months
measure: Structural MRI - Post-intervention Right Dentate Gyrus Head
timeFrame: 4 months
Secondary outcomes:
measure: Aerobic Capacity
timeFrame: 4 months
measure: Muscle Strength
timeFrame: 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Karin Schon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.