Comparing the Effects of Combining Cognitive and Physical Exercise Training on Cognition, and Cerebral Blood Flow Regulation in Men and Women With Chronic Heart Failure
NCT04970888, Not applicable, Recruiting, Montreal Heart Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparing the Effects of Combining Cognitive and Physical Exercise Training on Cognition, and Cerebral Blood Flow Regulation in Men and Women With Chronic Heart Failure | ClinicalTrials.gov |
| NCT number | NCT04970888 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 216 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Montreal Heart Institute | ClinicalTrials.gov |
| Conditions | Chronic Heart Failure, Aging | ClinicalTrials.gov |
| Interventions | Cognitive training, Exercise training, Usual care | ClinicalTrials.gov |
| First posted | 2021-07-21 | ClinicalTrials.gov |
| Last updated | 2025-12-02 | ClinicalTrials.gov |
Registered outcomes 21
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 6 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 6 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 6 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 6 months | Validated remote version of neuropsychological tests (Composite Z-score). | ClinicalTrials.gov |
| Secondary | Change in cerebral autoregulation - frontal cortical region | Baseline and post-intervention at 6 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 6 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 pulsatility - cortical frontal region | Baseline and post-intervention at 6 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 6 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 6 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 |
| Other | Change in cardiorespiratory fitness | Baseline and post-intervention at 6 months | Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min) | ClinicalTrials.gov |
| Other | Change in 6-min walking test performance | Baseline and post-intervention at 6 months | maximum distance performed in 6 minutes (distance, m) | ClinicalTrials.gov |
| Other | Change in upper limb muscle strength | Baseline and post-intervention at 6 months | Grip strength test score (kg). | ClinicalTrials.gov |
| Other | Change in quality of life | Baseline and post-intervention at 6 months | score on the 23 items of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | ClinicalTrials.gov |
| Other | Change in perceived self care behaviour | Baseline and post-intervention at 6 months | European Heart Failure Self-care Behaviour Scale (EHFScB-9) will be completed. This self-reported questionnaire assesses the adherence to different self-care behaviours (e.g., eating low-salt diet, etc.). | ClinicalTrials.gov |
| Other | Change in anxiety | Baseline and post-intervention at 6 months | State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety). | ClinicalTrials.gov |
| Other | Change in depressive symptoms | Baseline and post-intervention at 6 months | Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology). | ClinicalTrials.gov |
| Other | Change in sleep quality | Baseline and post-intervention at 6 months | Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology). | ClinicalTrials.gov |
| Other | Cognitive reserve | Baseline | Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve). | ClinicalTrials.gov |
| Other | Genotyping data | baseline | genotyping data that include the APOE gene | ClinicalTrials.gov |
| Other | Change in NT-pro-BNP | Baseline and post-intervention at 6 months | NT-pro-BNP (ng/L) | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42327429 | DERIVED | 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)