Trial Outcomes & Findings for Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study (NCT NCT05652140)
NCT ID: NCT05652140
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
159 participants
Primary outcome timeframe
30 minutes each at the Baseline and the Follow-Up visit at Month 18
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
57
|
59
|
|
Overall Study
COMPLETED
|
15
|
5
|
35
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
16
|
22
|
31
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
16
|
22
|
31
|
Baseline Characteristics
Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study
Baseline characteristics by cohort
| Measure |
High-Risk With Decreased CRF
n=22 Participants
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.
|
High-Risk With Increased CRF
n=21 Participants
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.
|
Low-Risk With Decreased CRF
n=57 Participants
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.
|
Low-Risk With Increased CRF
n=59 Participants
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.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Aged between 50-70 year-old
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
57 participants
n=5 Participants
|
59 participants
n=4 Participants
|
159 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
57 participants
n=5 Participants
|
59 participants
n=4 Participants
|
159 participants
n=21 Participants
|
|
Stroop response time (RT)
|
730.68 ms
STANDARD_DEVIATION 84.52 • n=5 Participants
|
678.90 ms
STANDARD_DEVIATION 86.19 • n=7 Participants
|
722.12 ms
STANDARD_DEVIATION 86.13 • n=5 Participants
|
701.81 ms
STANDARD_DEVIATION 67.91 • n=4 Participants
|
710.06 ms
STANDARD_DEVIATION 80.49 • n=21 Participants
|
PRIMARY outcome
Timeframe: 30 minutes each at the Baseline and the Follow-Up visit at Month 18Inhibitory 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.
Outcome measures
| Measure |
High-Risk With Decreased CRF
n=15 Participants
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.
|
High-Risk With Increased CRF
n=5 Participants
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.
|
Low-Risk With Decreased CRF
n=35 Participants
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.
|
Low-Risk With Increased CRF
n=28 Participants
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.
|
|---|---|---|---|---|
|
Changes in Inhibitory Performance: Stroop Task
|
1.66 ms
Standard Error 13.30
|
-29.85 ms
Standard Error 3.21
|
21.49 ms
Standard Error 8.75
|
-20.13 ms
Standard Error 9.78
|
PRIMARY outcome
Timeframe: 30 minutes each at the Baseline and the Follow-Up visit at Month 18The 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.
Outcome measures
| Measure |
High-Risk With Decreased CRF
n=15 Participants
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.
|
High-Risk With Increased CRF
n=5 Participants
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.
|
Low-Risk With Decreased CRF
n=35 Participants
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.
|
Low-Risk With Increased CRF
n=28 Participants
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.
|
|---|---|---|---|---|
|
Changes in Neuroelectrical Activities
|
-1.80 microvolt
Standard Error 0.90
|
2.81 microvolt
Standard Error 1.76
|
-1.20 microvolt
Standard Error 0.61
|
0.57 microvolt
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 5 minutes at the Baseline Stage.Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412)
Outcome measures
| Measure |
High-Risk With Decreased CRF
n=22 Participants
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.
|
High-Risk With Increased CRF
n=21 Participants
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.
|
Low-Risk With Decreased CRF
n=57 Participants
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.
|
Low-Risk With Increased CRF
n=59 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants for Whom ApoE Genotype Was Determined
|
22 Participants
|
21 Participants
|
57 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 30 minutes each at the Baseline and the Follow-Up visit at Month 18Participants' 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.
Outcome measures
| Measure |
High-Risk With Decreased CRF
n=15 Participants
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.
|
High-Risk With Increased CRF
n=5 Participants
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.
|
Low-Risk With Decreased CRF
n=35 Participants
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.
|
Low-Risk With Increased CRF
n=28 Participants
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.
|
|---|---|---|---|---|
|
Physical Fitness Measurements: Changes in Aerobic Fitness
|
-4.03 ml·kg-1·min-1
Standard Error 3.18
|
1.52 ml·kg-1·min-1
Standard Error 2.08
|
-4.76 ml·kg-1·min-1
Standard Error 3.65
|
3.28 ml·kg-1·min-1
Standard Error 4.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
High-Risk With Increased CRF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Risk With Decreased CRF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Risk With Increased CRF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Risk With Decreased CRF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yu-Kai Chang
Department of Physical Education and Sport Sciences, National Taiwan Normal University
Phone: +886277493223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place