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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-060697 | Other Grant/Funding Number | Veterans Affairs |
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The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.
Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.
The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.
In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.
Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.
The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stretching Exercise Intervention | Experimental | A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. |
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| Aerobic Exercise Intervention | Experimental | B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. |
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| Self Monitoring Intervention | Experimental | C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretching Exercise Intervention | Behavioral | A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate Cardiovascular Efficiency After Aerobic Exercise | Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment. | Baseline, 12 weeks, 24 weeks |
| Estimate of Cardiovascular Efficiency After Balance Training | Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes. | Baseline, 12 weeks, 24 weeks |
| Silent Period Duration After Exercise Cycling Program | Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds | Baseline, 12 weeks, 24 weeks |
| Silent Period Duration for Balance Group | Ipsilateral silent period duration as assessed by TMS | Baseline, 12 weeks, 24 weeks |
| fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise | Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition. | Baseline to 24 Weeks with cross-over |
| fMRI Interhemispheric Inhibition Improvement After Balance Training | Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Heart Rate Zone for Balance First Participants | Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve. | 24 and 48 weeks |
| Target Heart Rate Zone After Aerobic Exercise First |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith M. McGregor, PhD MS BA | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29354049 | Result | McGregor KM, Crosson B, Mammino K, Omar J, Garcia PS, Nocera JR. Influences of 12-Week Physical Activity Interventions on TMS Measures of Cortical Network Inhibition and Upper Extremity Motor Performance in Older Adults-A Feasibility Study. Front Aging Neurosci. 2018 Jan 4;9:422. doi: 10.3389/fnagi.2017.00422. eCollection 2017. | |
| 28367334 |
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Community-dwelling individuals were recruited for participation using approved flyer and advertising materials. All participants gave voluntary written consent prior to participation. After consenting, participants were randomly assigned to one of two 12-week exercise interventions involving a followed by cross-over to the other intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Aerobic Exercise, Then Balance Training | Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session. |
| FG001 | Experimental: Balance Training, Then Aerobic Exercise | Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Crossover Exercise Interventions |
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| Home Based Exercise Program |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Interventions for Crossover Design | This study was a cross-over design with two groups to which participants were randomized. Group one received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention. Group two received the balance intervention for 12 weeks and then crossed over into the aerobic exercise intervention. All completing participants then engaged in a home based exercise program during which they were instructed to exercise thrice weekly over 24 weeks. |
| Units | Counts |
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| 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 | Estimate Cardiovascular Efficiency After Aerobic Exercise | Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment. | Estimated VO2 peak values in ml/kg(min) | Posted | Mean | Standard Deviation | ml/kg(min) | Baseline, 12 weeks, 24 weeks |
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60 month. Participants were assessed at baseline, after 12-weeks, after 24 weeks and after 48 weeks. Measurements at 12 weeks represent first intervention. Measurements at 24 weeks represent measure after cross-over into alternate intervention. All participants then went through a home-based exercise program, which is the 48 week assessment. Note: Participants may have withdrawn from the study prior to completing the home-based exercise program.
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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 | Experimental Intervention: Aerobic Exercise First | Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session. Participants later crossed over into the Balance condition and were assessed at 24 weeks. After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm. |
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Local procurement difficulties limited remote tracking of participants in 6-month home exercise arm of program. This caused lower-than-expected adherence and negatively affected long-term outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keith McGregor | Health Science Specialist | 4043216111 | 126792 | keith.mcgregor2@va.gov |
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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 5, 2019 | Sep 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum.
C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer
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| Aerobic Exercise Intervention | Behavioral | Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum. |
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| Self Monitoring | Behavioral | 6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling) |
|
| Baseline, 12 weeks, 24 weeks |
| Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention | Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min). | 24 and 48 weeks |
| Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention | VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. | 24 and 48 weeks |
| Comparison of Silent Period Duration After Aerobic Exercise | Comparison of silent period duration at 24 weeks compared to baseline | Baseline, 12 weeks, 24 weeks |
| Comparison of Silent Period Duration After Balance Exercise | Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs. | 24 and 48 weeks |
Targeted Heart Rate Zone among participants compared among short term exercise groups
| 24 and 48 weeks |
| Heart Rate Workload After Home Based Intervention | Measured heart rate after home based intervention Technical implementation at the facility level prevented acquisition of these metrics until late in the project. | 24 and 48 weeks |
| Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6. |
| 30542314 | Result | McGregor KM, Crosson B, Krishnamurthy LC, Krishnamurthy V, Hortman K, Gopinath K, Mammino KM, Omar J, Nocera JR. Effects of a 12-Week Aerobic Spin Intervention on Resting State Networks in Previously Sedentary Older Adults. Front Psychol. 2018 Nov 27;9:2376. doi: 10.3389/fpsyg.2018.02376. eCollection 2018. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cardiovascular Efficiency | Mean | Standard Deviation | ml/kg(min) |
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| Ipsilateral Silent Period | Mean | Standard Deviation | milliseconds |
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| FMRI of Right Motor Cortex | Mean | Standard Deviation | area under curve |
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| Primary | Estimate of Cardiovascular Efficiency After Balance Training | Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes. | Sedentary older adults who engaged in less than 45 minutes of regular exercise per week | Posted | Mean | Standard Deviation | ml/kg(min) | Baseline, 12 weeks, 24 weeks |
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| Primary | Silent Period Duration After Exercise Cycling Program | Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds | Posted | Mean | Standard Deviation | milliseconds | Baseline, 12 weeks, 24 weeks |
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| Primary | Silent Period Duration for Balance Group | Ipsilateral silent period duration as assessed by TMS | Sedentary older adults engaging in less than 45 minutes of total activity per week | Posted | Mean | Standard Deviation | milliseconds | Baseline, 12 weeks, 24 weeks |
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| Primary | fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise | Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition. | Analysis of area under curve of right primary motor cortical area | Posted | Mean | Standard Deviation | Z-transformed impulse response function | Baseline to 24 Weeks with cross-over |
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| Primary | fMRI Interhemispheric Inhibition Improvement After Balance Training | Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition. | Posted | Mean | Standard Deviation | Z-transformed impulse response function | Baseline, 12 weeks, 24 weeks |
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| Primary | Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention | Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min). | Posted | Mean | Standard Deviation | ml/kg(min) | 24 and 48 weeks |
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| Primary | Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention | VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. | Participants completed both exercise interventions but completed Balance training prior to engaging in aerobic exercise training. | Posted | Mean | Standard Deviation | ml/kg(min) | 24 and 48 weeks |
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| Primary | Comparison of Silent Period Duration After Aerobic Exercise | Comparison of silent period duration at 24 weeks compared to baseline | Posted | Mean | Standard Deviation | milliseconds | Baseline, 12 weeks, 24 weeks |
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| Primary | Comparison of Silent Period Duration After Balance Exercise | Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs. | Participants completing balance training then crossing over into aerobic exercise were then tested for effects of facility based treatments against home exercise. | Posted | Mean | Standard Deviation | milliseconds | 24 and 48 weeks |
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| Secondary | Target Heart Rate Zone for Balance First Participants | Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve. | Posted | Mean | Standard Deviation | percentage of time | 24 and 48 weeks |
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| Secondary | Target Heart Rate Zone After Aerobic Exercise First | Targeted Heart Rate Zone among participants compared among short term exercise groups | Posted | Mean | Standard Deviation | percentage of time | 24 and 48 weeks |
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| Secondary | Heart Rate Workload After Home Based Intervention | Measured heart rate after home based intervention Technical implementation at the facility level prevented acquisition of these metrics until late in the project. | Participants completing home based interventions compared to facility based interventions - measured in time in aerobic zone. | Posted | Mean | Standard Deviation | percentage of time | 24 and 48 weeks |
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| 0 |
| 17 |
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| 17 |
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| 17 |
| EG001 | Experimental Intervention: Balance Exercise First | Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. Participants later crossed over into the Aerobic Exercise condition and were assessed at 24 weeks. After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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