AgingECENCT02775760
The Entorhinal Cortex and Aerobic Exercise in Aging
A study testing Cardiovascular endurance and Strength, balance, and flexibility in people with Aging, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cardiovascular endurance and Strength, balance, and flexibility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 9 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Cardiovascular endurance, Strength, balance, and flexibility
- 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
- Medical subject headings
- Motor Activity, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular enduranceBehavioural
Physical exercise at the Boston University Fitness and Recreation Center
Strength, balance, and flexibilityBehavioural
Physical exercise at the Boston University Fitness and Recreation Center
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular endurance | Experimental | Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Receives: Behavioral: Cardiovascular endurance |
| Strength, balance, and flexibility | Active comparator | Participants will undergo Strength, balance, and flexibility training. Receives: Behavioral: Strength, balance, and flexibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (2)
Aerobic Capacity
Participants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity. Aerobic capacity is the maximum amount of oxygen (O2;(expressed in volume: VO2) a person can utilize during strenuous exercise. This maximum volume of oxygen is known as VO2max or aerobic capacity. For this study, we measured heart rate during the treadmill test and estimated VO2max from heart rate, thus we estimated VO2max rather than measured oxygen and carbondioxyde in the breath while exercising. VO2max is expressed in milliliters per kilogram of body weight per minute (ml/kg/min). We calculated percentage change from baseline to post-intervention.
Measured: 4 months
Muscle Strength
Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength. Percentage change in chess press weight lifted is reported in results.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start22 Jan 2018
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Why it stopped: Suspended due to Covid-19 policies, then terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Georgia Institute of Technology, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karin Schon, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775760
- Sponsor's protocol ID
- H-34579
- Other IDs
- R21AG049968
- Acronym
- ECE
- Status last verified
- May 2023
- First submitted
- 11 May 2016
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosario MA, Kern KL, Mumtaz S, Storer TW, Schon K. Cardiorespiratory fitness is associated with cortical thickness of medial temporal brain areas associated with spatial cognition in young but not older adults. Eur J Neurosci. 2024 Jan;59(1):82-100. doi: 10.1111/ejn.16200. Epub 2023 Dec 6.
PubMed 38056827Kern 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.
PubMed 33325614
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Entorhinal Cortex and Aerobic Exercise in Aging
- ClinicalTrials.gov ID
- NCT02775760
- Acronym / sponsor ID
- ECE / H-34579
- Conditions
- Aging
- Keywords
- brain, brain mapping, cognition, exercise, physical activity, hippocampus, entorhinal cortex, spatial navigation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended due to Covid-19 policies, then terminated.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Georgia Institute of Technology, National Institute on Aging (NIA)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular endurance | Experimental | Behavioral: Cardiovascular enduranceParticipants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity |
| Strength, balance, and flexibility | Active comparator | Behavioral: Strength, balance, and flexibilityParticipants will undergo Strength, balance, and flexibility training. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular endurancePhysical exercise at the Boston University Fitness and Recreation Center | Behavioural | Cardiovascular endurance |
| Strength, balance, and flexibilityPhysical exercise at the Boston University Fitness and Recreation Center | Behavioural | Strength, balance, and flexibility |
Primary outcome
Functional MRI - Right Subiculum
Time frame: 0 months-baseline (pre-intervention)
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.
Structural MRI - Right Dentate Gyrus Head
Time frame: 0 months-baseline (pre-intervention)
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.
Cognitive Test Performance: Spatial Memory
Time frame: 4 months
Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.
Cognitive Test Performance: Virtual Navigation
Time frame: 4 months
Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.
Functional MRI - Post-intervention Right Subiculum
Time frame: 4 months
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.
Structural MRI - Post-intervention Right Dentate Gyrus Head
Time frame: 4 months
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.
2 secondary outcomes
Aerobic Capacity
Time frame: 4 months
Muscle Strength
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38056827Rosario MA, Kern KL, Mumtaz S, Storer TW, Schon K. Cardiorespiratory fitness is associated with cortical thickness of medial temporal brain areas associated with spatial cognition in young but not older adults. Eur J Neurosci. 2024 Jan;59(1):82-100. doi: 10.1111/ejn.16200. Epub 2023 Dec 6.
- Derived from this study: PubMed 33325614Kern 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.
- Brain Plasticity and Neuroimaging Laboratory at Boston UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Schon, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular endurance and Strength, balance, and flexibility in people with Aging, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI - Right Subiculum (time frame: 0 months-baseline (pre-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.