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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002737 | U.S. NIH Grant/Contract | View source |
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Due to COVID-19 Pandemic
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic exercise program on cognition and determine the relationship between cognitive improvements and Transcranial Magnetic Stimulation (TMS) neuroplasticity.
The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic exercise program on cognition and determine the relationship between cognitive improvements and neuroplasticity. The primary study aims include: 1) Quantify improvements in cognitive performance after 8 weeks (150 min per week) of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age; 2) Determine an association between changes in plasticity, aerobic capacity, and cognitive performance overall and by cognitive domain, after 8 weeks of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age.
Due to challenges posed by the COVID-19 pandemic, social distancing practices, and aiming to create a feasible scenario to continue the current study, we propose an additional option to safely adapt study methods to deliver the study in a home-based, fully remote manner. Importantly, this scenario also presents as an opportunity to collect meaningful data on our specific aims while translating this successful research program into a remote/home-based mode of delivery. A remote/home based option may also yield valuable preliminary data that will be relevant for planning future exercise studies in aging adults in the present "new normal". Therefore, this research project consist of two equivalent options:
Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic.
Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group (All participants) | Experimental | Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Participants were provided with option to participate remotely due to COVID-19 pandemic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Participants are provided the option to participate remotely due to COVID-19 pandemic, as detailed below. Both options are designed to be equivalent in intervention and outcome measures. Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic. Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TMS Plasticity Measures | Index of the duration of the Theta-burst stimulation (TBS)-induced modulation of corticospinal excitability. This outcome measure refers to the identification of the time point (T5, T10, T15, T20 and T30). at which the normalized motor evoked potential (MEP) amplitude returns to baseline values (T0 or Baseline). This measure will be in Minutes Post Theta-Burst stimulation. This is a neurophysiological measure, and no group-based norms apply. | Baseline and Post-intervention (after 8 weeks of exercise) |
| Cognitive Performance (RBANS) | Cognitive performance will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) a neuropsychological test battery in executive function, processing speed, learning, and language. It is made up of a series of twelve subtests that take approximately 30 minutes. For each of these, a lower number correct is indicative of a higher cognitive deficit. Subtests are their scales are: RBANS Semantic Fluency (0-unlimited), RBANS Picture Naming (0-10), RBANS List Learning (0-40), RBANS List Recall (0-10), RBANS Story Memory (0-24), RBANS Story Recall (0-12), RBANS List Recognition (0-20), RBANS Digit Span (0-16), RBANS Figure Recall (0-20), RBANS Coding (0-89), RBANS Figure Copy (0-20), RBANS Line Orientation (0-20). | Baseline and Post-intervention (after 8 weeks of exercise) |
| Cognitive Performance (DKEFS) | Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language. The D-KEFS Verbal Fluency Test measures the ability to generate words fluently in an effortful phonemic format (letter fluency),from overlearned concepts (category fluency), and simultaneously shifting between overlearned concepts (category switching). Raw scores (correct responses, correct number of switches between categories) are converted to scaled scores with a mean of 10 and a standard deviation of 3. Higher scores reflect higher verbal fluency, and an increase in score pre-post would indicate improvement. | Baseline and Post-intervention (after 8 weeks of exercise) |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating Markers of Endothelium Function (BDNF) | Blood samples will be collected to measure: brain-derived neurotrophic factor (BDNF) levels (measured as pg/mL). | Baseline |
| Change in Cardiorespiratory Fitness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce R Gomes-Osman, PT, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34817393 | Derived | Cabral DF, Hinchman CA, Nunez C, Rice J, Loewenstein DA, Cahalin LP, Rundek T, Pascual-Leone A, Gomes-Osman J. Harnessing Neuroplasticity to Promote Brain Health in Aging Adults: Protocol for the MOVE-Cog Intervention Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33589. doi: 10.2196/33589. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group (All Participants) | Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Aerobic Exercise in person: Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Option A: IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic. Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics Data was collected and reported on those participants that completed the in-person and remote procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group (All Participants) | Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Aerobic Exercise in person: Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Two equivalent options provided for participation, to accommodate for COVID-19 pandemic guidelines. Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic. Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in TMS Plasticity Measures | Index of the duration of the Theta-burst stimulation (TBS)-induced modulation of corticospinal excitability. This outcome measure refers to the identification of the time point (T5, T10, T15, T20 and T30). at which the normalized motor evoked potential (MEP) amplitude returns to baseline values (T0 or Baseline). This measure will be in Minutes Post Theta-Burst stimulation. This is a neurophysiological measure, and no group-based norms apply. | In 2020, due to challenges posed by the COVID-19 pandemic, social distancing practices, and aiming to create a feasible scenario to continue the study, an additional option was added to safely adapt study methods to deliver a home-based, fully remote program given that the duration of the pandemic was unknown at this time point. The study moved forward utilizing these two options, which were not designed as separate study arms but rather designed to be equivalent. | Posted | Mean | Standard Deviation | minutes | Baseline and Post-intervention (after 8 weeks of exercise) |
|
8 weeks
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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 | Exercise Group (All Participants) | Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Aerobic Exercise in person: Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Two equivalent options for in-person and remote participation were offered in response to the COVID-19 pandemic. Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic. Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines, as mentioned above). |
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The COVID-19 pandemic and resulting changes to remote clinical research modalities impacted the implementation of the study. Although the study was modified to accommodate remote participation, this modality prohibited the collection of clinical measures that required physical presence, such as TMS and blood collection, and required the adjustment for other measures, such as cardiorespiratory fitness assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Gomes-Osman | University of Miami | 305-284-2632 | j.gomes@miami.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 | Feb 22, 2021 | Jul 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2021 | Jun 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Cognitive Performance (Digital Span) |
Digital span - Subtest of the Wechsler Adult Intelligence Scale fourth edition; Three sections: Digits Forward, Digits Backward, and Digits Sequencing. For each section, min. raw score value: 0; max. raw score value: 16. Higher the score, better the outcome. |
| Baseline and Post-intervention (after 8 weeks of exercise) |
Heart rate recovery (HRR) is the primary measure for cardiorespiratory fitness. HRR is defined as the change in the heart rate from the peak of exercise to the heart rate after 1-min (HRR-1) and 2-min test cessation (HRR-2).
| Baseline and Post-intervention (after 8 weeks of exercise) |
| Circulating Markers of Endothelium Function (VEGF) | Blood samples will be collected to measure vascular endothelial growth factor (VEGF) (measured as pg/mL). | Baseline |
| Circulating Markers of Endothelium Function (Hs-CRP) | Blood samples will be collected to measure high sensitivity C reactive protein (HS-CRP) (measured as mg/L). | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Health Status | Count of Participants | Participants |
|
| MoCA - Montreal Cognitive Assessment Global Cognition | Montreal Cognitive Assessment or MoCA total scores. The Montreal Cognitive Assessment (MoCA) was initially developed as a test for mild cognitive impairment. It assesses seven areas of cognition for a maximal score of 30 (ranges 0-30). Higher scores indicate greater function. | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| Exercise Group-All Participants |
Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Aerobic Exercise in person: Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session. Option A: IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic. Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines). |
|
|
| Primary | Cognitive Performance (RBANS) | Cognitive performance will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) a neuropsychological test battery in executive function, processing speed, learning, and language. It is made up of a series of twelve subtests that take approximately 30 minutes. For each of these, a lower number correct is indicative of a higher cognitive deficit. Subtests are their scales are: RBANS Semantic Fluency (0-unlimited), RBANS Picture Naming (0-10), RBANS List Learning (0-40), RBANS List Recall (0-10), RBANS Story Memory (0-24), RBANS Story Recall (0-12), RBANS List Recognition (0-20), RBANS Digit Span (0-16), RBANS Figure Recall (0-20), RBANS Coding (0-89), RBANS Figure Copy (0-20), RBANS Line Orientation (0-20). | Eligibility criteria met. Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline. | Posted | Mean | Standard Deviation | mean total correct responses | Baseline and Post-intervention (after 8 weeks of exercise) |
|
|
|
| Primary | Cognitive Performance (DKEFS) | Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language. The D-KEFS Verbal Fluency Test measures the ability to generate words fluently in an effortful phonemic format (letter fluency),from overlearned concepts (category fluency), and simultaneously shifting between overlearned concepts (category switching). Raw scores (correct responses, correct number of switches between categories) are converted to scaled scores with a mean of 10 and a standard deviation of 3. Higher scores reflect higher verbal fluency, and an increase in score pre-post would indicate improvement. | Eligibility criteria met. Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post-intervention (after 8 weeks of exercise) |
|
|
|
| Primary | Cognitive Performance (Digital Span) | Digital span - Subtest of the Wechsler Adult Intelligence Scale fourth edition; Three sections: Digits Forward, Digits Backward, and Digits Sequencing. For each section, min. raw score value: 0; max. raw score value: 16. Higher the score, better the outcome. | Eligibility criteria met. Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Post-intervention (after 8 weeks of exercise) |
|
|
|
| Secondary | Circulating Markers of Endothelium Function (BDNF) | Blood samples will be collected to measure: brain-derived neurotrophic factor (BDNF) levels (measured as pg/mL). | COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued; therefore, blood was not collected for all participants. Blood was only able to be collected for 24 participants at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| Secondary | Change in Cardiorespiratory Fitness | Heart rate recovery (HRR) is the primary measure for cardiorespiratory fitness. HRR is defined as the change in the heart rate from the peak of exercise to the heart rate after 1-min (HRR-1) and 2-min test cessation (HRR-2). | Participants were considered at risk of cognitive decline due to their age, sedentary activity, and other lifestyle factors known to contribute to cognitive decline. | Posted | Mean | Standard Deviation | heart beats per minute | Baseline and Post-intervention (after 8 weeks of exercise) |
|
|
|
| Secondary | Circulating Markers of Endothelium Function (VEGF) | Blood samples will be collected to measure vascular endothelial growth factor (VEGF) (measured as pg/mL). | COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued; therefore, blood was not collected for all participants. Blood was only able to be collected for 24 participants at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| Secondary | Circulating Markers of Endothelium Function (Hs-CRP) | Blood samples will be collected to measure high sensitivity C reactive protein (HS-CRP) (measured as mg/L). | COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued; therefore, blood was not collected for all participants. Blood was only able to be collected for 24 participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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| RBANS picture naming - Post-intervention |
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| RBANS list learning - Baseline |
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| RBANS list learning - Post-intervention |
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| RBANS list recall - Baseline |
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| RBANS list recall - Post-intervention |
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| RBANS story memory - Baseline |
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| RBANS story memory - Post-intervention |
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| RBANS story recall - Baseline |
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| RBANS story recall - Post-intervention |
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| RBANS list recognition - Baseline |
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| RBANS list recognition - Post-intervention |
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| RBANS digital span - Baseline |
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| RBANS digital span - Post-intervention |
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| RBANS figure recall - Baseline |
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| RBANS figure recall - Post-intervention |
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| RBANS coding - Baseline |
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| RBANS coding -Post-intervention |
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| RBANS figure copy - Baseline |
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| RBANS figure copy - Post-intervention |
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| RBANS line orientation - Baseline |
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| RBANS line orientation - Post-intervention |
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| DKEFS category fluency - Post-intervention |
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| DKEFS category switching - Baseline |
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| DKEFS category switching - Post-intervention |
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| DKEFS category switching accuracy - Baseline |
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| DKEFS category switching accuracy - Post-intervention |
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| digital span backward - post-intervention |
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| digital span sequence - baseline |
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| digital span sequence - post-intervention |
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| Title | Measurements |
|---|---|
|
| HRR2 - Post-intervention |
|