Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study
NCT05652140, Completed, National Taiwan Normal University; results first posted 2024-08-19
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study | ClinicalTrials.gov |
| NCT number | NCT05652140 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 159 participants, actual | ClinicalTrials.gov |
| Lead sponsor | National Taiwan Normal University | ClinicalTrials.gov |
| Conditions | Aging, Cognitive Change | ClinicalTrials.gov |
| Interventions | Data collections | ClinicalTrials.gov |
| First posted | 2022-12-15 | ClinicalTrials.gov |
| Last updated | 2024-11-15 | ClinicalTrials.gov |
| Results first posted | 2024-08-19 | ClinicalTrials.gov |
| Limitations and caveats | 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. | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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) | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Other | 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. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Changes in Inhibitory Performance: Stroop Task | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | ms | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in Neuroelectrical Activities | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | microvolt | MEAN | ClinicalTrials.gov | |
| SECONDARY | Number of Participants for Whom ApoE Genotype Was Determined | 5 minutes at the Baseline Stage. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Physical Fitness Measurements: Changes in Aerobic Fitness | 30 minutes each at the Baseline and the Follow-Up visit at Month 18 | ml·kg-1·min-1 | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | Changes in Higher Order Executive Performance: Tower of London Test | 30 minutes each at the Baseline and the Follow-Up Stages. | 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. | ClinicalTrials.gov |
Results by group 16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Changes in Inhibitory Performance: Stroop Task | High-Risk With Decreased CRF | 1.66 | Standard Error 13.30 | ms | ClinicalTrials.gov | |
| Changes in Inhibitory Performance: Stroop Task | High-Risk With Increased CRF | -29.85 | Standard Error 3.21 | ms | ClinicalTrials.gov | |
| Changes in Inhibitory Performance: Stroop Task | Low-Risk With Decreased CRF | 21.49 | Standard Error 8.75 | ms | ClinicalTrials.gov | |
| Changes in Inhibitory Performance: Stroop Task | Low-Risk With Increased CRF | -20.13 | Standard Error 9.78 | ms | ClinicalTrials.gov | |
| Changes in Neuroelectrical Activities | High-Risk With Decreased CRF | -1.80 | Standard Error 0.90 | microvolt | ClinicalTrials.gov | |
| Changes in Neuroelectrical Activities | High-Risk With Increased CRF | 2.81 | Standard Error 1.76 | microvolt | ClinicalTrials.gov | |
| Changes in Neuroelectrical Activities | Low-Risk With Decreased CRF | -1.20 | Standard Error 0.61 | microvolt | ClinicalTrials.gov | |
| Changes in Neuroelectrical Activities | Low-Risk With Increased CRF | 0.57 | Standard Error 0.67 | microvolt | ClinicalTrials.gov | |
| Number of Participants for Whom ApoE Genotype Was Determined | High-Risk With Decreased CRF | 22 | Participants | ClinicalTrials.gov | ||
| Number of Participants for Whom ApoE Genotype Was Determined | High-Risk With Increased CRF | 21 | Participants | ClinicalTrials.gov | ||
| Number of Participants for Whom ApoE Genotype Was Determined | Low-Risk With Decreased CRF | 57 | Participants | ClinicalTrials.gov | ||
| Number of Participants for Whom ApoE Genotype Was Determined | Low-Risk With Increased CRF | 59 | Participants | ClinicalTrials.gov | ||
| Physical Fitness Measurements: Changes in Aerobic Fitness | High-Risk With Decreased CRF | -4.03 | Standard Error 3.18 | ml·kg-1·min-1 | ClinicalTrials.gov | |
| Physical Fitness Measurements: Changes in Aerobic Fitness | High-Risk With Increased CRF | 1.52 | Standard Error 2.08 | ml·kg-1·min-1 | ClinicalTrials.gov | |
| Physical Fitness Measurements: Changes in Aerobic Fitness | Low-Risk With Decreased CRF | -4.76 | Standard Error 3.65 | ml·kg-1·min-1 | ClinicalTrials.gov | |
| Physical Fitness Measurements: Changes in Aerobic Fitness | Low-Risk With Increased CRF | 3.28 | Standard Error 4.29 | ml·kg-1·min-1 | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | High-Risk With Decreased CRF | 22 | ClinicalTrials.gov | |
| Overall Study | STARTED | High-Risk With Increased CRF | 21 | ClinicalTrials.gov | |
| Overall Study | STARTED | Low-Risk With Decreased CRF | 57 | ClinicalTrials.gov | |
| Overall Study | STARTED | Low-Risk With Increased CRF | 59 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | High-Risk With Decreased CRF | 15 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | High-Risk With Increased CRF | 5 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Low-Risk With Decreased CRF | 35 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Low-Risk With Increased CRF | 28 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | High-Risk With Decreased CRF | 7 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | High-Risk With Increased CRF | 16 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Low-Risk With Decreased CRF | 22 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Low-Risk With Increased CRF | 31 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 12
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | High-Risk With Increased CRF | 0 | 22 | ClinicalTrials.gov |
| Total, all-cause mortality | High-Risk With Decreased CRF | 0 | 21 | ClinicalTrials.gov |
| Total, all-cause mortality | Low-Risk With Increased CRF | 0 | 57 | ClinicalTrials.gov |
| Total, all-cause mortality | Low-Risk With Decreased CRF | 0 | 59 | ClinicalTrials.gov |
| Total, other adverse events | High-Risk With Increased CRF | 0 | 22 | ClinicalTrials.gov |
| Total, other adverse events | High-Risk With Decreased CRF | 0 | 21 | ClinicalTrials.gov |
| Total, other adverse events | Low-Risk With Increased CRF | 0 | 57 | ClinicalTrials.gov |
| Total, other adverse events | Low-Risk With Decreased CRF | 0 | 59 | ClinicalTrials.gov |
| Total, serious adverse events | High-Risk With Increased CRF | 0 | 22 | ClinicalTrials.gov |
| Total, serious adverse events | High-Risk With Decreased CRF | 0 | 21 | ClinicalTrials.gov |
| Total, serious adverse events | Low-Risk With Increased CRF | 0 | 57 | ClinicalTrials.gov |
| Total, serious adverse events | Low-Risk With Decreased CRF | 0 | 59 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Tower Planning | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)