The Entorhinal Cortex and Aerobic Exercise in Aging

NCT02775760 | Terminated Results

• 2 other identifiers: H-34579R21AG049968
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Functional MRI - Right Subiculum

  The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner. Data reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.

  0 months-baseline (pre-intervention)

• Structural MRI - Right Dentate Gyrus Head

  Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.

  0 months-baseline (pre-intervention)

• Cognitive Test Performance: Spatial Memory

  Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.

  4 months

• Cognitive Test Performance: Virtual Navigation

  Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.

  4 months

• Functional MRI - Post-intervention Right Subiculum

  The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner. Data reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.

  4 months

• Structural MRI - Post-intervention Right Dentate Gyrus Head

  Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.

  4 months

Secondary Outcomes (2)

• Aerobic Capacity

  4 months

• Muscle Strength

  4 months

Study Arms (2)

Cardiovascular endurance

EXPERIMENTAL

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

Behavioral: Cardiovascular endurance

Strength, balance, and flexibility

ACTIVE COMPARATOR

Participants will undergo Strength, balance, and flexibility training.

Behavioral: Strength, balance, and flexibility

Interventions

Cardiovascular endurance BEHAVIORAL

Physical exercise at the Boston University Fitness and Recreation Center

Cardiovascular endurance

Strength, balance, and flexibility BEHAVIORAL

Physical exercise at the Boston University Fitness and Recreation Center

Strength, balance, and flexibility

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Brigham and Women's Hospital: collaborator
• Georgia Institute of Technology: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 33325614 DERIVED

Related Links

• Brain Plasticity and Neuroimaging Laboratory at Boston University

MeSH Terms

Conditions

Motor Activity; Spatial Navigation

Interventions

Pliability

Condition Hierarchy (Ancestors)

Behavior; Spatial Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Limitations and Caveats

Note the small number of participants with complete pre- and post-intervention datasets (N=19). This number was even lower for functional MRI data analyses due to excessive head motion. This limits the interpretation of the results. In addition, the trial was also suspended and then terminated due to the SARS-CoV-2 (COVID-19) pandemic, which also contributed to data loss.

Results Point of Contact

• Title: Karin Schon, Ph.D.
• Organization: Boston University Chobanian & Avedisian School of Medicine

kschon@bu.edu

(617) 358-2118

Study Officials

• Karin Schon, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 18, 2016
• Study Start: January 22, 2018
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: May 10, 2023
• Results First Posted: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)