Aging, Cognitive Change
Conditions
Keywords
physical fitness, Apolipoprotein E, event-related potential
Brief summary
The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.
Detailed description
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: 1. An exploration of the associations of, as well as the interactions between, CRF assessed at the Baseline Stage, and the ApoE genotype, along with cognitive functions in cognitively healthy late-middle-aged older adults. 2. The employing of an event-related potential (ERP) to investigate the associations between the baseline CRF, the ApoE genotype, and cognitive functions in cognitively healthy late-middle-aged older adults, as well as the potential underlying neuroelectrical mechanisms. 3. An investigation of the interactions between the changes of CRFs assessed at the Baseline and the Follow-Up Stages and the ApoE genotype in relation to neurocognitive function, as well as the underlying neuroelectrical mechanisms, in cognitively healthy late-middle-aged older adults.
Interventions
OTHERData collections
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
Sponsors
National Taiwan Normal University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* right handed * no history of cardiorespiratory disease * normal or corrected-to-normal vision based on the 20/20 standard * no risk of performing physical activities, as measured by the Physical Activity Readiness Questionnaire
Exclusion criteria
* the scores of Mini-Mental Status Examination (MMSE) \< 25 and cognitively intact upon study entry * history of psychiatric or neurological diseases * color-blindness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Inhibitory Performance: Stroop Task | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | 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. |
| Changes in Neuroelectrical Activities | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Whom ApoE Genotype Was Determined | 5 minutes at the Baseline Stage. | Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412) |
| Physical Fitness Measurements: Changes in Aerobic Fitness | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Higher Order Executive Performance: Tower of London Test | 30 minutes each at the Baseline and the Follow-Up Stages. | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 21 |
| 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. | 57 |
| 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. | 59 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 16 | 22 | 31 |
Baseline characteristics
| Characteristic | High-Risk With Decreased CRF | High-Risk With Increased CRF | Low-Risk With Decreased CRF | Low-Risk With Increased CRF | Total |
|---|---|---|---|---|---|
| Age, Customized Aged between 50-70 year-old | 22 participants | 21 participants | 57 participants | 59 participants | 159 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 21 Participants | 57 Participants | 59 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 22 participants | 21 participants | 57 participants | 59 participants | 159 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 44 Participants | 45 Participants | 120 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 13 Participants | 14 Participants | 39 Participants |
| Stroop response time (RT) | 730.68 ms STANDARD_DEVIATION 84.52 | 678.90 ms STANDARD_DEVIATION 86.19 | 722.12 ms STANDARD_DEVIATION 86.13 | 701.81 ms STANDARD_DEVIATION 67.91 | 710.06 ms STANDARD_DEVIATION 80.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 | 0 / 57 | 0 / 59 |
| other Total, other adverse events | 0 / 22 | 0 / 21 | 0 / 57 | 0 / 59 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 | 0 / 57 | 0 / 59 |
Outcome results
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.
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Risk With Decreased CRF | Changes in Inhibitory Performance: Stroop Task | 1.66 ms | Standard Error 13.3 |
| High-Risk With Increased CRF | Changes in Inhibitory Performance: Stroop Task | -29.85 ms | Standard Error 3.21 |
| Low-Risk With Decreased CRF | Changes in Inhibitory Performance: Stroop Task | 21.49 ms | Standard Error 8.75 |
| Low-Risk With Increased CRF | Changes in Inhibitory Performance: Stroop Task | -20.13 ms | Standard Error 9.78 |
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.
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Risk With Decreased CRF | Changes in Neuroelectrical Activities | -1.80 microvolt | Standard Error 0.9 |
| High-Risk With Increased CRF | Changes in Neuroelectrical Activities | 2.81 microvolt | Standard Error 1.76 |
| Low-Risk With Decreased CRF | Changes in Neuroelectrical Activities | -1.20 microvolt | Standard Error 0.61 |
| Low-Risk With Increased CRF | Changes in Neuroelectrical Activities | 0.57 microvolt | Standard Error 0.67 |
Secondary
Number of Participants for Whom ApoE Genotype Was Determined
Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412)
Time frame: 5 minutes at the Baseline Stage.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Risk With Decreased CRF | Number of Participants for Whom ApoE Genotype Was Determined | 22 Participants |
| High-Risk With Increased CRF | Number of Participants for Whom ApoE Genotype Was Determined | 21 Participants |
| Low-Risk With Decreased CRF | Number of Participants for Whom ApoE Genotype Was Determined | 57 Participants |
| Low-Risk With Increased CRF | Number of Participants for Whom ApoE Genotype Was Determined | 59 Participants |
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.
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Risk With Decreased CRF | Physical Fitness Measurements: Changes in Aerobic Fitness | -4.03 ml·kg-1·min-1 | Standard Error 3.18 |
| High-Risk With Increased CRF | Physical Fitness Measurements: Changes in Aerobic Fitness | 1.52 ml·kg-1·min-1 | Standard Error 2.08 |
| Low-Risk With Decreased CRF | Physical Fitness Measurements: Changes in Aerobic Fitness | -4.76 ml·kg-1·min-1 | Standard Error 3.65 |
| Low-Risk With Increased CRF | Physical Fitness Measurements: Changes in Aerobic Fitness | 3.28 ml·kg-1·min-1 | Standard Error 4.29 |
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.
Time frame: 30 minutes each at the Baseline and the Follow-Up Stages.
Population: 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.