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The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.
The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions. The three main purposes of the current research project seek to achieve:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Risk with increased CRF | ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. |
| |
| High-Risk with decreased CRF | ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. |
| |
| Low-Risk with increased CRF | Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. |
| |
| Low-Risk with decreased CRF | Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collections | Other | Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Inhibitory Performance: Stroop Task | Inhibitory performance was assessed using the computerized Stroop task at the Baseline and at the Follow-Up assessments. The difference in response time (RT) between the Baseline and the Follow-Up Stages was calculated as the index of the inhibitory performance. | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
| Changes in Neuroelectrical Activities | The neuroelectrical activities (P3 component) during the Stroop task were recorded and analyzed using the Neuroscan system. The difference in P3 amplitudes of incongruent trials between the Baseline and the Follow-Up Stages was calculated as the index of the neuroelectrical index. | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Whom ApoE Genotype Was Determined | Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412) | 5 minutes at the Baseline Stage. |
| Physical Fitness Measurements: Changes in Aerobic Fitness |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Higher Order Executive Performance: Tower of London Test | Higher order executive performance was assessed using the Tower of London Test at the baseline and at the follow-up assessments. Changes in higher order executive performance from Baseline to the Follow-Up Stages were assessed. | 30 minutes each at the Baseline and the Follow-Up Stages. |
Inclusion Criteria:
Exclusion Criteria:
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Cognitively healthy late-middle-aged older adults recruited from the northern part of Taiwan.
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Kai Chang, Ph.D. | Department of Physical Education and Sport Sciences, National Taiwan Normal University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Education and Sport Sciences, National Taiwan Normal University | Taipei | 106308 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Risk With Decreased CRF | ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| FG001 | High-Risk With Increased CRF | ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| FG002 | Low-Risk With Decreased CRF | Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| FG003 | Low-Risk With Increased CRF | Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Risk With Decreased CRF | ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| BG001 | High-Risk With Increased CRF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Changes in Inhibitory Performance: Stroop Task | Inhibitory performance was assessed using the computerized Stroop task at the Baseline and at the Follow-Up assessments. The difference in response time (RT) between the Baseline and the Follow-Up Stages was calculated as the index of the inhibitory performance. | Posted | Mean | Standard Error | ms | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
|
2.5 years.
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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 | High-Risk With Increased CRF | ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
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Due to the substantial overlapping of the study period with the COVID-19 pandemic, a larger-than-expected number of participants withdrew following the completion of the baseline stage.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yu-Kai Chang | Department of Physical Education and Sport Sciences, National Taiwan Normal University | +886277493223 | yukaichangnew@gmail.com |
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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 | Dec 12, 2022 | Apr 27, 2023 | Prot_SAP_000.pdf |
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Participants' aerobic fitness was estimated using the submaximal cycle ergometer test at the baseline and at the follow-up assessments. The difference in maximum oxygen consumption (VO2 max) between the Baseline and the Follow-Up Stages was calculated as the index of aerobic fitness. |
| 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| BG002 | Low-Risk With Decreased CRF | Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| BG003 | Low-Risk With Increased CRF | Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stroop response time (RT) | Response time (RT) during the incongruent trials was recorded as one of the behavioral indexes. | Mean | Standard Deviation | ms |
|
ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
| OG002 | Low-Risk With Decreased CRF | Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
| OG003 | Low-Risk With Increased CRF | Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. |
|
|
| Primary | Changes in Neuroelectrical Activities | The neuroelectrical activities (P3 component) during the Stroop task were recorded and analyzed using the Neuroscan system. The difference in P3 amplitudes of incongruent trials between the Baseline and the Follow-Up Stages was calculated as the index of the neuroelectrical index. | Posted | Mean | Standard Error | microvolt | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
|
|
|
| Secondary | Number of Participants for Whom ApoE Genotype Was Determined | Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412) | Posted | Count of Participants | Participants | 5 minutes at the Baseline Stage. |
|
|
|
| Secondary | Physical Fitness Measurements: Changes in Aerobic Fitness | Participants' aerobic fitness was estimated using the submaximal cycle ergometer test at the baseline and at the follow-up assessments. The difference in maximum oxygen consumption (VO2 max) between the Baseline and the Follow-Up Stages was calculated as the index of aerobic fitness. | Posted | Mean | Standard Error | ml·kg-1·min-1 | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 |
|
|
|
| Other Pre-specified | Changes in Higher Order Executive Performance: Tower of London Test | Higher order executive performance was assessed using the Tower of London Test at the baseline and at the follow-up assessments. Changes in higher order executive performance from Baseline to the Follow-Up Stages were assessed. | The Tower of London Test, a pre-specified Primary Outcome Measure, was not administered to any participants due to unforeseen constraints in practical resource availability at the study sites (i.e., unavailability of required test materials and time limitations that precluded its inclusion within the study timeline). Consequently, no data was collected for this outcome measure. | Posted | 30 minutes each at the Baseline and the Follow-Up Stages. |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | High-Risk With Decreased CRF | ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Low-Risk With Increased CRF | Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. | 0 | 57 | 0 | 57 | 0 | 57 |
| EG003 | Low-Risk With Decreased CRF | Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Data collections: Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness. | 0 | 59 | 0 | 59 | 0 | 59 |
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