Exercise, Brain, and Cardiovascular Health
NCT03841669, Not applicable, Completed, University of Pittsburgh; results first posted 2025-02-24
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise, Brain, and Cardiovascular Health | ClinicalTrials.gov |
| NCT number | NCT03841669 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 130 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Pittsburgh | ClinicalTrials.gov |
| Conditions | Cardiovascular Diseases | ClinicalTrials.gov |
| Interventions | Aerobic Exercise Group, Physical Activity & Health Information Group | ClinicalTrials.gov |
| First posted | 2019-02-15 | ClinicalTrials.gov |
| Last updated | 2025-02-24 | ClinicalTrials.gov |
| Results first posted | 2025-02-24 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Hippocampal Volume | Baseline & 12 months | Magnetic Resonance Imaging (MRI) will be used to measure the structure of the brain. Segmentation algorithms applied to structural MRI images will be used to compute the volume of the hippocampus in particular, which will be evaluated for change over the course of the trial. | ClinicalTrials.gov |
| Secondary | Change in Systolic Blood Pressure Responses to Behavioral Tasks | Baseline & 12 months | Average systolic blood pressure will be computed during a resting baseline period and during the performance of two behavioral tasks, (1) a Stroop color-word interference task and (2) a multi-source interference task. Mean baseline levels of systolic blood pressure will be subtracted from mean levels averaged across the two tasks to compute response scores, and changes in task-response scores will be evaluated over the course of the trial. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability (HRV) | Baseline & 12 months | Heart rate variability will be computed from inter-beat intervals derived from electrocardiographic recordings while participants rest in the seated position. Average heart rate variability values from the recording period will be assessed for their change over the trial. Here, we report the natural log-transformed variance of high-frequency (HF) heart rate variability. | ClinicalTrials.gov |
| Other | Change in fMRI | Baseline & 12 months | Changes in task invoked activity will be measured during an emotion regulation task. | ClinicalTrials.gov |
| Other | Change in Reappraisal and Suppression Scores | Baseline, 6-month (if applicable) & 12 months | Participants will complete the Emotion Regulation Questionnaire (ERQ). They rate how strongly they agree with 10 statements and emotion regulation abilities are calculated by their responses. A minimum score would be 10 and a maximum score would be 70, with 70 indicating superior emotion regulation abilities. | ClinicalTrials.gov |
| Other | Change in Perceived Stress Scale (PSS) | Baseline, 6-month (if applicable) & 12 months | This will be calculated via the PSS 4-item scale. Scores are calculated by averaging responses from 10 questions with a minimum score of 0 and a maximum score of 40. 40 indicates more stress. | ClinicalTrials.gov |
| Other | Change in Self-esteem | Baseline, 6-month (if applicable) & 12 months | Participants will complete a questionnaire related to self-esteem via the Rosenberg Self Esteem Scale. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Sum scores for all 10 items are calculated with items 2, 5, 6, 8, 9 being reverse scored. Higher scores indicate higher self-esteem. | ClinicalTrials.gov |
| Other | Change in Blood Pressure | Baseline, 6-month (if applicable), & 12 months | An average systolic blood pressure (SBP) will be calculated for an average over all baseline, 6-month (if applicable) and 12-month visits. | ClinicalTrials.gov |
| Other | Change in Cardiorespiratory Fitness | Baseline, 6-month (if applicable), & 12-month | Fitness is assessed by maximal graded exercise testing. Oxygen uptake (VO2) will be measured from expired air samples taken at 15s intervals until a peak VO2, the highest VO2, is attained at the point of test termination due to symptom limitation and/or volitional exhaustion. | ClinicalTrials.gov |
| Other | Change in Fasting Glucose. | Baseline, 6-month (if applicable) & 12 month | Blood will be drawn at 3 time points throughout the intervention starting at baseline to measure changes in fasting glucose. | ClinicalTrials.gov |
| Other | Change in Insulin Resistance. | Baseline, 6-month (if applicable) & 12 month | Blood will be drawn at 3 time points throughout the intervention starting at baseline to measure changes in insulin resistance. | ClinicalTrials.gov |
| Other | Mediation | Baseline, 6 month (if applicable) and 12 month. | The outcome will be measured by whether the statistical mediation model that contains brain and peripheral physiological mediators is significant. By definition such a model must contain multiple outcome variables, but the outcome here isn't a measurable outcome but rather whether the statistical model with these variables reaches statistical significance. | ClinicalTrials.gov |
| Other | Change in Heart Rate | Baseline, 6-month (if applicable), & 12 months | An average heart rate will be calculated for an average over all baseline, 6-month (if applicable) and 12-month visits. | ClinicalTrials.gov |
| Other | Change in Daily Life Ecological Monitoring Assessment (EMA) | Baseline & 12 months | Participants will complete several questions on a smart phone at various times throughout the day based on a prompt to learn more about positive and negative affect. An average positive and negative affect score will be computed. | ClinicalTrials.gov |
| Other | Change in Daily Life SBP Reactivity | Baseline & 12 months | Participants will have their blood pressure taken while answering questions about daily stressors and an average SBP score will be computed over the course of the wear period. | ClinicalTrials.gov |
| Other | Change in Negative and Positive Affect | Baseline & 12 months | This will be calculated via scores from the Positive and Negative Affect Scale. Scores can range from 1 to 100, with 1 meaning less positive affect and 100 meaning more positive affect. | ClinicalTrials.gov |
| Other | Change in Baroreflex Sensitivity (BRS) | Baseline & 12 months | Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. BRS will be derived in part from the EKG signal. | ClinicalTrials.gov |
| Other | Change in Pulse Wave Velocity (PWV) | Baseline & 12 months | Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. PWV will be derived in part from the EKG signal. | ClinicalTrials.gov |
| Other | Change in Vasodilation (Reactive Hyperemia) | Baseline & 12 months | Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. Vasodilation (reactive hyperemia) will be derived in part from the EKG signal. | ClinicalTrials.gov |
| Other | Change in Brain Activity | Baseline & 12 months | MRI will be used to measure changes in brain activity including task invoked activation patterns. | ClinicalTrials.gov |
Outcomes 23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Hippocampal Volume | Baseline & 12 months | All randomized participants were included in intention-to-treat (ITT) analyses. | mm^3 | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Systolic Blood Pressure Responses to Behavioral Tasks | Baseline & 12 months | Randomized participants who had baseline systolic blood pressure measures available were included in intention-to-treat (ITT) analyses. | mmHg | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Heart Rate Variability (HRV) | Baseline & 12 months | Randomized participants who had heart rate variability measures available at baseline were included in intention-to-treat (ITT) analyses. | ln[ms²] | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Change in fMRI | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Reappraisal and Suppression Scores | Baseline, 6-month (if applicable) & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Perceived Stress Scale (PSS) | Baseline, 6-month (if applicable) & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Self-esteem | Baseline, 6-month (if applicable) & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Blood Pressure | Baseline, 6-month (if applicable), & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Cardiorespiratory Fitness | Baseline, 6-month (if applicable), & 12-month | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Fasting Glucose. | Baseline, 6-month (if applicable) & 12 month | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Insulin Resistance. | Baseline, 6-month (if applicable) & 12 month | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Mediation | Baseline, 6 month (if applicable) and 12 month. | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Heart Rate | Baseline, 6-month (if applicable), & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Daily Life Ecological Monitoring Assessment (EMA) | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Daily Life SBP Reactivity | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Negative and Positive Affect | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Baroreflex Sensitivity (BRS) | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Pulse Wave Velocity (PWV) | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Vasodilation (Reactive Hyperemia) | Baseline & 12 months | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Change in Brain Activity | Baseline & 12 months | ClinicalTrials.gov |
Results by group 6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Hippocampal Volume | Aerobic Exercise Group | -15.4 | 95% Confidence Interval -79.3 to 48.4 | mm^3 | ClinicalTrials.gov | |
| Change in Hippocampal Volume | Physical Activity & Health Information Group | -49.9 | 95% Confidence Interval -112.8 to 13 | mm^3 | ClinicalTrials.gov | |
| Change in Systolic Blood Pressure Responses to Behavioral Tasks | Aerobic Exercise Group | -0.932 | 95% Confidence Interval -3.7 to 1.836 | mmHg | ClinicalTrials.gov | |
| Change in Systolic Blood Pressure Responses to Behavioral Tasks | Physical Activity & Health Information Group | -3.519 | 95% Confidence Interval -6.2 to -0.835 | mmHg | ClinicalTrials.gov | |
| Change in Heart Rate Variability (HRV) | Aerobic Exercise Group | 0.0022 | 95% Confidence Interval -0.257 to 0.261 | ln[ms²] | ClinicalTrials.gov | |
| Change in Heart Rate Variability (HRV) | Physical Activity & Health Information Group | -0.2035 | 95% Confidence Interval -0.472 to 0.065 | ln[ms²] | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Aerobic Exercise Group | 64 | ClinicalTrials.gov | |
| Overall Study | STARTED | Physical Activity & Health Information Group | 66 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Aerobic Exercise Group | 41 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Physical Activity & Health Information Group | 41 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Aerobic Exercise Group | 23 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Physical Activity & Health Information Group | 25 | ClinicalTrials.gov |
Adverse events 6
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 |
|---|---|---|---|---|---|---|---|
| other | Cardiovascular | Vascular disorders | Aerobic Exercise Group | 1 | 64 | ClinicalTrials.gov | |
| other | Cardiovascular | Vascular disorders | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | Aerobic Exercise Group | 5 | 64 | ClinicalTrials.gov | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov | |
| serious | Tumor | Surgical and medical procedures | Aerobic Exercise Group | 1 | 64 | ClinicalTrials.gov | |
| serious | Tumor | Surgical and medical procedures | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Aerobic Exercise Group | 0 | 64 | ClinicalTrials.gov |
| Total, all-cause mortality | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov |
| Total, other adverse events | Aerobic Exercise Group | 6 | 64 | ClinicalTrials.gov |
| Total, other adverse events | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov |
| Total, serious adverse events | Aerobic Exercise Group | 1 | 64 | ClinicalTrials.gov |
| Total, serious adverse events | Physical Activity & Health Information Group | 0 | 66 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37968003 | DERIVED | PubMed |
Grants 1
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 |
|---|---|---|---|---|---|---|
| P01HL040962 | Biobehavioral Studies of Cardiovascular Disease | GIANAROS, PETER J | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1988 to 2022 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aerobic Exercise Group vs Physical Activity & Health Information Group: deaths from any cause | Trial comparisons |
| Aerobic Exercise Group vs Physical Activity & Health Information Group: serious adverse events | Trial comparisons |
Tests 3
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 |
|---|---|---|
| Emotion Regulation Task | Other outcome | ConductCognition |
| Multi-Source Interference Task | Secondary outcome | ConductCognition |
| 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)