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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG049968 | U.S. NIH Grant/Contract | View source |
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Suspended due to Covid-19 policies, then terminated.
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Georgia Institute of Technology | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiovascular endurance | Experimental | Participants 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 | Participants will undergo Strength, balance, and flexibility training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular endurance | Behavioral | Physical exercise at the Boston University Fitness and Recreation Center |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Karin Schon, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38056827 | Derived | 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. | |
| 33325614 | Derived | 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. |
| Label | URL |
|---|---|
| Brain Plasticity and Neuroimaging Laboratory at Boston University | View source |
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Participants were first pre-screened over the telephone. At their initial visit, they gave written informed consent for all study procedures (screening, MRI, etc.). Thus, we consider every participant as enrolled who provided consent, and the number of participants started is not the same as the number of participants who were assigned to each Arm. 8 enrolled participants did not start the exercise intervention, 21 were not eligible after screening, leaving 29 who started the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiovascular Endurance | Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center |
| FG001 | Strength, Balance, and Flexibility | Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiovascular Endurance | Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 3 participants were excluded due to excess head motion during functional MRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training) | Posted | Mean | Standard Deviation | BOLD Signal (beta weight) | 0 months-baseline (pre-intervention) |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiovascular Endurance | Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fainting | Gastrointestinal disorders | Non-systematic Assessment | 1 participant reported being admitted to an emergency department due to fainting spells |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karin Schon, Ph.D. | Boston University Chobanian & Avedisian School of Medicine | (617) 358-2118 | kschon@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | Dec 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D065854 | Spatial Navigation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D013037 | Spatial Behavior |
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| ID | Term |
|---|---|
| D018583 | Pliability |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| Strength, balance, and flexibility | Behavioral | Physical exercise at the Boston University Fitness and Recreation Center |
|
| 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 |
| 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. | 4 months |
| Strength, Balance, and Flexibility |
Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Cardiovascular Endurance | Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center |
| OG001 | Strength, Balance, and Flexibility | Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center |
|
|
| Primary | 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. | 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training) | Posted | Mean | Standard Deviation | volume in cubic mm | 0 months-baseline (pre-intervention) |
|
|
|
| Primary | Cognitive Test Performance: Spatial Memory | Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance. | Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform. | Posted | 4 months |
|
|
| Primary | 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. | Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform. | Posted | 4 months |
|
|
| Primary | 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. | 3 participants were excluded due to excess head motion during fMRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training) | Posted | Mean | Standard Deviation | BOLD Signal (beta weight) | 4 months |
|
|
|
| Primary | 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. | 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training) | Posted | Mean | Standard Deviation | volume in cubic mm | 4 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Percentage change from baseline | 4 months |
|
|
|
| Secondary | 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. | All participants who completed the intervention were included in the analysis (12 cardiovascular endurance group, 7 strength, balance, and flexibility group). | Posted | Median | Inter-Quartile Range | Percentage change from baseline | 4 months |
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| 3 |
| 17 |
| EG001 | Strength, Balance, and Flexibility | Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center | 0 | 12 | 1 | 12 | 3 | 12 |
|
| Sciatica pain | Nervous system disorders | Non-systematic Assessment |
|
| Sudden tachycardia | Cardiac disorders | Non-systematic Assessment | Participant was subsequently diagnosed with atrial fibrillation (no hospitalization needed), and participation was terminated |
|
| Concussion | Nervous system disorders | Non-systematic Assessment | Unrelated to research study (due to accident that happened at participant's home) |
|
| Back soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | right foot |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| tachycardia and chest tightness | Cardiac disorders | Non-systematic Assessment | EMT suspected heart rate monitor dysfunction and a subsequent panic attack |
|
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