A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.
NCT04962061, Not applicable, Completed, Louis Bherer
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors. | ClinicalTrials.gov |
| NCT number | NCT04962061 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 159 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Louis Bherer | ClinicalTrials.gov |
| Conditions | Aging, Cardiovascular Risk Factor | ClinicalTrials.gov |
| Interventions | Cognitive Training, Aerobic and resistance exercises, Stretching and Toning | ClinicalTrials.gov |
| First posted | 2021-07-14 | ClinicalTrials.gov |
| Last updated | 2026-08-27 | ClinicalTrials.gov |
Registered outcomes 51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in general cognitive functioning | Baseline and post-intervention at 12 months. | Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning). | ClinicalTrials.gov |
| Primary | Change in processing speed | Baseline and post-intervention at 12 months. | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | ClinicalTrials.gov |
| Primary | Change in executive functions | Baseline and post-intervention at 12 months. | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | ClinicalTrials.gov |
| Primary | Change in episodic memory | Baseline and post-intervention at 12 months. | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | ClinicalTrials.gov |
| Secondary | Change in cerebral autoregulation - frontal cortical region | Baseline and post-intervention at 12 months. | Variations of prefrontal cortical oxygen saturation (rSO2, \[HbO\]/(\[HbO\]+\[HbR\])) will be measured by Near Infrared Spectroscopy (NIRS), as a surrogate of cortical blood flow. Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of oxygen saturation measures and variations of peripheral blood pressure. | ClinicalTrials.gov |
| Secondary | Change in cerebral autoregulation - middle cerebral arteries | Baseline and post-intervention at 12 months. | Variations of cerebral blood flow velocity (cm/s) at the level of the middle cerebral artery will be measured by Transcranial Doppler (TCD). Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of cerebral blood flow measures and variations of peripheral blood pressure. | ClinicalTrials.gov |
| Secondary | Change in cerebral vasoreactivity - whole brain | Baseline and post-intervention at 12 months. | Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured by Arterial Spin Labeling MRI in two third of the study participants who do not present contra-indication for imaging studies. | ClinicalTrials.gov |
| Secondary | Change in cerebral vasoreactivity - prefrontal cortex | Baseline and post-intervention at 12 months. | Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region. | ClinicalTrials.gov |
| Secondary | Change in cerebral vasoreactivity - middle cerebral arteries | Baseline and post-intervention at 12 months. | Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries | ClinicalTrials.gov |
| Secondary | Change in cerebral pulsatility - cortical frontal region | Baseline and post-intervention at 12 months. | Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region. | ClinicalTrials.gov |
| Secondary | Change in cerebral pulsatility - middle cerebral arteries | Baseline and post-intervention at 12 months. | Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries. | ClinicalTrials.gov |
| Secondary | Change in cerebral activity | Baseline and post-intervention at 12 months. | Significant changes in brain activity evoked by a Stroop task relative to baseline will be assessed by t-statistics maps, computed from variations of \[HbO\] and \[HbR\] measured by NIRS at the prefrontal cortex. | ClinicalTrials.gov |
| Secondary | Change in brain structure | Baseline and post-intervention at 12 months. | Multimodal structural MRI will be performed in two third of the study participants who do not present contra-indication for imaging studies, to measure regional cerebral volumes, as well as volume of angiopathic markers (eg lacunes, microbleeds, white matter hyperintensities), in cm3. | ClinicalTrials.gov |
| Other | Change in cardiorespiratory fitness | Baseline and post-intervention at 12 months. | Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)). | ClinicalTrials.gov |
| Other | Change in peripheral endothelial function | Baseline and post-intervention at 12 months. | Fow-mediated dilation of the brachial artery (%). | ClinicalTrials.gov |
| Other | Change in central artery stiffness | Baseline and post-intervention at 12 months. | Carotid femoral pulse-wave velocity (m/s). | ClinicalTrials.gov |
| Other | Change in walking speed | Baseline and post-intervention at 12 months. | Timed 10-meter walking test (cm/s). | ClinicalTrials.gov |
| Other | Change in functional mobility | Baseline and post-intervention at 12 months. | Timed Time up and Go test (s). | ClinicalTrials.gov |
| Other | Change in Balance performance | Baseline and post-intervention at 12 months. | Timed one-leg standing test (s). | ClinicalTrials.gov |
| Other | Change in lower limb muscles strength | Baseline and post-intervention at 12 months. | Timed Sit-to-Stand test (s) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
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 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 24
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 10882764 | BACKGROUND | PubMed |
| 12661673 | BACKGROUND | PubMed |
| 15851723 | BACKGROUND | PubMed |
| 16420143 | BACKGROUND | PubMed |
| 16467562 | BACKGROUND | PubMed |
| 17466428 | BACKGROUND | PubMed |
| 18188871 | BACKGROUND | PubMed |
| 18848880 | BACKGROUND | PubMed |
| 19520452 | BACKGROUND | PubMed |
| 20847403 | BACKGROUND | PubMed |
| 21143340 | BACKGROUND | PubMed |
| 22629239 | BACKGROUND | PubMed |
| 23179255 | BACKGROUND | PubMed |
| 24313901 | BACKGROUND | PubMed |
| 25323165 | BACKGROUND | PubMed |
| 25599569 | BACKGROUND | PubMed |
| 25616781 | BACKGROUND | PubMed |
| 25771249 | BACKGROUND | PubMed |
| 25812012 | BACKGROUND | PubMed |
| 26433119 | BACKGROUND | PubMed |
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 1
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 | Secondary 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)