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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG062548-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.
Aim 1: Compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (ND) elderly and AD subjects. ND (n=30) and AD (n=30) subjects will undergo a single bout of moderate intensity (45-55% HRR) or higher intensity (65-75% HRR) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). Investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in ND subjects than in AD subjects.
Aim 2: Characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in ND and AD subjects. The acute biomarker response to exercise and the effect on cognition has not been examined in aged or AD cohorts. Investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, AUC) compared to acute moderate intensity exercise, and that this response will be greater in ND than in AD subjects. Investigators further hypothesize that lactate AUC will track negatively with change in cerebral glucose metabolism and cognitive performance. Although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Intensity Aerobic Exercise | Experimental | 45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR |
|
| High Intensity Aerobic Exercise | Experimental | 65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio) | FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI). | Resting Vs acute exercise bout: ~1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Area Under the Curve | Change in lactate AUC between the resting and exercise condition | Resting Vs acute exercise bout: ~1 month |
| Brain-derived Neurotrophic Factor (BDNF) Change | Pre/post change in circulating Brain Derived Neurotrophic Factor between the resting and exercise conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39258961 | Background | Green ZD, John CS, Kueck PJ, Blankenship AE, Kemna RE, Johnson CN, Yoksh LE, Best SR, Donald JS, Mahnken JD, Burns JM, Vidoni ED, Morris JK. Acute exercise alters brain glucose metabolism in aging and Alzheimer's disease. J Physiol. 2026 Mar;604(6):2473-2490. doi: 10.1113/JP286923. Epub 2024 Sep 11. | |
| 34051350 | Background | Green ZD, John CS, Kueck PJ, Burns JM, Perry M, Donald J, Mahnken JD, Honea RA, Vidoni ED, Morris JK. Rationale and methods to characterize the acute exercise response in aging and Alzheimer's Disease: the AEROBIC pilot study. Contemp Clin Trials. 2021 Aug;107:106457. doi: 10.1016/j.cct.2021.106457. Epub 2021 May 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Intensity Aerobic Exercise | 45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
| FG001 | High Intensity Aerobic Exercise | 65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Intensity Aerobic Exercise | 45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
| 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 | Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio) | FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI). | Posted | Mean | Standard Deviation | SUVR | Resting Vs acute exercise bout: ~1 month |
|
1 month
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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 | Moderate Intensity Aerobic Exercise | 45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal ECG | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Morris | University of Kansas Medical Center | 9139457675 | jmorris2@kumc.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 | Nov 12, 2020 | Jan 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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2 arm, cross-sectional
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| Resting Vs acute exercise bout: ~1 month |
| BG001 | High Intensity Aerobic Exercise | 65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload |
|
|
| Secondary | Lactate Area Under the Curve | Change in lactate AUC between the resting and exercise condition | Individuals who completed both visits with blood draws available | Posted | Mean | Standard Deviation | AUC change (mmol/L*min) | Resting Vs acute exercise bout: ~1 month |
|
|
|
| Secondary | Brain-derived Neurotrophic Factor (BDNF) Change | Pre/post change in circulating Brain Derived Neurotrophic Factor between the resting and exercise conditions | Posted | Mean | Standard Deviation | pg/mL | Resting Vs acute exercise bout: ~1 month |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | High Intensity Aerobic Exercise | 65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload | 0 | 31 | 0 | 31 | 2 | 31 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Covid diagnosis | Infections and infestations | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |