N/A
Completed N=151
Stress Management and Biomarkers of Risk in Cardiac Rehabilitation
Source: ClinicalTrials.gov NCT00981253 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Absolute Composite Stress Score — 77.6; 67.5 Mean rank score
Summary
The purpose of this study is to assess the extent to which combining exercise and stress management training (SMT) is more effective at improving biomarkers in vulnerable cardiac patients compared to exercise-based cardiac rehabilitation alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Composite Stress Score |
77.6; 67.5 | — |
| PRIMARY Change From Baseline to 12 Weeks in Individual Scaled Scores |
-3.5; -2.6; -5.6; -2.6; -4.8; -3.3 | <0.05 sig |
| SECONDARY Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. |
0; 2; 1; 6; 9; 11 | — |
| SECONDARY Change in High-sensitivity C-Reactive Protein |
-0.9; -0.4 | .95 |
| SECONDARY Heart Rate Variability During Controlled Breathing (HRV-DB) |
13.1; 26.0 | 0.99 |
| SECONDARY Baroreflex Sensitivity |
0.47; 0.93 | 0.99 |
| SECONDARY Heart Rate Variability During Rest |
0.17; 0.28; 0.08; 0.22 | 0.99 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Coronary Heart Disease (CHD)
- Eligibility for Cardiac Rehabilitation (CR) in North Carolina
- Capacity to give informed consent and follow study procedures
Exclusion Criteria
- Received heart transplant
- LVEF 200/120 mm Hg
- Left main disease > 50%
- Unable to comply with assessment procedures
- Unwilling or unable to be randomized to treatment groups
- Primary diagnosis of the following psychiatric disorders: schizophrenia, dementia, current delirium, or other psychotic disorder
- Current alcohol or substance abuse disorder
- Acute suicide risk
- Actively undergoing ongoing psychiatric treatment
Data sourced from ClinicalTrials.gov (NCT00981253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.