N/A N=151 Randomized Treatment

Stress Management and Biomarkers of Risk in Cardiac Rehabilitation

Coronary Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00981253 ↗

Enrolled (actual)

151

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Absolute Composite Stress Score — 77.6; 67.5 Mean rank score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SMT-enhanced Cardiac Rehabilitation (Behavioral); Standard Cardiac Rehabilitation (Behavioral)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2014

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

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.

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

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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.