Trial · NCT02516332
Exercise and Pharmacotherapy for Anxiety in Cardiac Patients
NCT02516332, Not applicable, Completed, Duke University; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exercise and Pharmacotherapy for Anxiety in Cardiac Patients. Trials, record NCT02516332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02516332
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exercise and Pharmacotherapy for Anxiety in Cardiac Patients
- NCT number
- NCT02516332
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 128 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Anxiety, Cardiovascular Disease
- Interventions
- Lexapro, Placebo, Supervised Aerobic Exercise
- First posted
- 2015-08-05
- Last updated
- 2021-06-11
- Results first posted
- 2021-06-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hospital Anxiety and Depression Scale (HADS), Anxiety | Baseline, 3 months | The Hospital Anxiety and Depression Scale, Anxiety, is a 7-item subscale with scores ranging from 0-21, with higher scores indicating more anxiety. |
| Secondary | Change in Heart Rate Variability, SDNN (Msec) | Baseline, 3 months | To quantify heart rate variability (HRV), an electrocardiogram was recorded for 24-hours using the 3-channel DigiTrak XT Holter recorder (Philips Healthcare, Andover, Massachusetts). Electrocardiographic data were downloaded and edited using the Philips Zymed Holter analysis software (2010 Plus/1810 series) and HRV was estimated from the standard deviation of the normal-to-normal R-R intervals (SDNN). |
| Secondary | Change in Baroreflex Sensitivity, ms/mm Hg | Baseline, 3 months | To assess baroreflex sensitivity (BRS), beat-by-beat systolic blood pressure (SBP) and heart rate (HR) were collected using the Nexfin noninvasive BP monitor (Bmeye, Amsterdam, Netherlands). BRS was estimated from the magnitude of the transfer function relating R-R interval oscillations to SBP oscillations across the 0.07 to 0.1299 Hz, or low frequency band. |
| Secondary | Change in Vascular Endothelial Function, Percentage of Dilation | Baseline, 3 months | Endothelial function, assessed by Flow-Mediated Dilation (FMD), was determined from longitudinal B-mode ultrasound images of the brachial artery. Images were obtained using an Acuson (Mountain View, California) Aspen ultrasound platform with an 11-MHz linear-array transducer after 10 min of supine relaxation and during reactive hyperemia, induced by the inflation of a forearm pneumatic occlusion cuff to suprasystolic pressure (about 200 mm Hg) and subsequent deflation after 5 min. FMD was defined as the maximum percentage change in arterial diameter relative to resting baseline from 10 to 120 s after deflation of the occlusion cuff. |
| Secondary | Change in Inflammation (C-Reactive Protein, ug/ml) | Baseline, 3 months | High-sensitivity C-reactive protein was quantified by ELISA (LabCorp). Values \>10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker. |
| Secondary | Change in Urinary Catecholamines (Epinephrine and Norepinephrine, Unit-weighted Z-score) | Baseline, 3 months | Urinary catecholamines, an index of sympathetic nervous system (SNS) activity, served as a biomarker of anxiety. Urinary concentrations of epinephrine (EPI) and norepinephrine (NE) were determined by high-pressure liquid chromatography (HPLC) with electrochemical detection (LabCorp). A composite 24-hr catecholamines z-score is presented. The z-score is the raw score minus the population mean, divided by the population standard deviation. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. |
| Secondary | Change in Lipids - Total Cholesterol, LDL (Low-density Lipoprotein), and HDL (High-density Lipoprotein); mg/dL | Baseline, 3 months | Lipids were obtained from fasting blood samples and assays were measured enzymatically (LabCorp). |
| Other | Change in Hospital Anxiety and Depression Scale, Total Score | 9 months, 15 months |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hospital Anxiety and Depression Scale (HADS), Anxiety | Baseline, 3 months | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Heart Rate Variability, SDNN (Msec) | Baseline, 3 months | msec | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Baroreflex Sensitivity, ms/mm Hg | Baseline, 3 months | ms/mm Hg | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Vascular Endothelial Function, Percentage of Dilation | Baseline, 3 months | percentage of dilation | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Inflammation (C-Reactive Protein, ug/ml) | Baseline, 3 months | ug/ml | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Urinary Catecholamines (Epinephrine and Norepinephrine, Unit-weighted Z-score) | Baseline, 3 months | z-score | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Lipids - Total Cholesterol, LDL (Low-density Lipoprotein), and HDL (High-density Lipoprotein); mg/dL | Baseline, 3 months | mg/dL | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Change in Hospital Anxiety and Depression Scale, Total Score | 9 months, 15 months |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS), Anxiety | Supervised Aerobic Exercise | -3.9 | 95% Confidence Interval -4.6 to -3.2 | score on a scale | |
| Change in Hospital Anxiety and Depression Scale (HADS), Anxiety | Lexapro | -5.7 | 95% Confidence Interval -6.4 to -5.0 | score on a scale | |
| Change in Hospital Anxiety and Depression Scale (HADS), Anxiety | Placebo | -3.5 | 95% Confidence Interval -4.6 to -2.5 | score on a scale | |
| Change in Heart Rate Variability, SDNN (Msec) | Supervised Aerobic Exercise | -0.3 | 95% Confidence Interval -22.5 to 22.0 | msec | |
| Change in Heart Rate Variability, SDNN (Msec) | Lexapro | -8.7 | 95% Confidence Interval -31.4 to 13.9 | msec | |
| Change in Heart Rate Variability, SDNN (Msec) | Placebo | -1.1 | 95% Confidence Interval -37.1 to 35.0 | msec | |
| Change in Baroreflex Sensitivity, ms/mm Hg | Supervised Aerobic Exercise | 1.2 | 95% Confidence Interval -7.0 to 9.4 | ms/mm Hg | |
| Change in Baroreflex Sensitivity, ms/mm Hg | Lexapro | 1.3 | 95% Confidence Interval -4.9 to 7.4 | ms/mm Hg | |
| Change in Baroreflex Sensitivity, ms/mm Hg | Placebo | 1.5 | 95% Confidence Interval -10.6 to 13.6 | ms/mm Hg | |
| Change in Vascular Endothelial Function, Percentage of Dilation | Supervised Aerobic Exercise | 0.7 | 95% Confidence Interval -0.2 to 1.5 | percentage of dilation |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Supervised Aerobic Exercise | 52 | |
| Overall Study | STARTED | Lexapro | 53 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Supervised Aerobic Exercise | 50 | |
| Overall Study | COMPLETED | Lexapro | 52 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Supervised Aerobic Exercise | 2 | |
| Overall Study | NOT COMPLETED | Lexapro | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Supervised Aerobic Exercise | 0 | 52 |
| Total, all-cause mortality | Lexapro | 0 | 53 |
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, other adverse events | Supervised Aerobic Exercise | 0 | 52 |
| Total, other adverse events | Lexapro | 0 | 53 |
| Total, other adverse events | Placebo | 0 | 23 |
| Total, serious adverse events | Supervised Aerobic Exercise | 0 | 52 |
| Total, serious adverse events | Lexapro | 0 | 53 |
| Total, serious adverse events | Placebo | 0 | 23 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02516332
GET https://conductscience.org/api/trials/v1/NCT02516332/results?page=2