An interventional study of SMT-enhanced Cardiac Rehabilitation and Standard Cardiac Rehabilitation in Coronary Heart Disease, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
Coronary heart disease (CHD) is the leading cause of death in the United States and in roughly half the cases its first clinical manifestations, myocardial infarction (MI) or sudden cardiac death (SCD), are fatal. There is considerable evidence that "stress" plays a significant and independent role in the occurrence of CHD and its complications. This evidence has provided the rationale for developing interventional strategies to reduce stress in susceptible individuals in order to modify the natural history of these clinical events. There are now promising data to suggest that stress management training (SMT) is one such approach, and that SMT can have beneficial effects on psychosocial and medical outcomes. However, many of the randomized clinical trials (RCTs) employing stress management approaches in CHD patients have had important methodological limitations and several of the larger RCTs have failed to demonstrate a benefit for SMT over usual care, raising questions about the value of SMT for patients with CHD. Reliance on "hard" clinical endpoints is problematic because studies require such large sample sizes that they are logistically difficult to conduct and are prohibitively expensive. The use of intermediate pathophysiologic endpoints that have been shown independently to be associated with increased risk represents a novel and exciting opportunity to examine the added value of SMT in exercise-based cardiac rehabilitation (CR) compared to CR without SMT on key biomarkers of risk in vulnerable CHD patients.
This 12-week study will enroll adults with stable CHD who are eligible for CR. Participants will be randomly assigned to either standard cardiac rehabilitation or standard cardiac rehabilitation enhanced with weekly SMT. Prior to randomization, medical screening, standardized psychosocial questionnaires, mental stress testing, assessment of diet and physical activity, and exercise testing will be conducted. Additional biomarkers of risk will be assessed through measures of flow-mediated vasodilation, inflammation, platelet function, stress hormones, baroreflex, and heart rate variability.
Participants assigned to CR alone will engage in supervised exercise routines 3 times per week. Participants will be encouraged to maintain consistent exercise duration and effort throughout each session. Participants assigned to CR enhanced with SMT will engage in standard exercise-based cardiac rehabilitation and also receive weekly group SMT. At the conclusion of the 12-week intervention, participants will return for repeat assessments of stress and biomarker measures. At 6 months, 12 months, and annually up to 4 years participants will be contacted for information regarding major adverse cardiovascular events, other medical events and medication use.
Additionally a group of age, gender, and disease matched cardiac patients referred to CR, during the same time interval, but who elected not to participate in CR will form a non-randomized comparison group for cardiac events.
Overall, 164 participants were consented for study participation at Duke University Medical Center. Of these, 151 participants were randomized to either Standard Cardiac Rehabilitation or Enhanced Cardiac Rehabilitation. Post-intervention assessments were completed on 145 participants; 151 participants were available for intention-to-treat analysis.
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This study's enrollment of 164 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.
Behavioral: SMT-enhanced Cardiac Rehabilitation
Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.
Behavioral: Standard Cardiac Rehabilitation
Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.
Supervised exercise, three times per week, for 12 weeks.
Absolute Composite Stress Score
A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2.
Time frame: Baseline; 12 weeks
Change From Baseline to 12 Weeks in Individual Scaled Scores
Beck Depression Inventory II: 21-item scale used to measure depression. Scores range from 0 to 63, with higher scores suggesting greater depressive symptoms. State-Trait Anxiety Inventory: 20-item scale which assess levels of state anxiety. Scores range from 20 to 80 with scores ≥40 suggesting clinically significant anxiety. General Health Questionnaire:12-item measure of general distress. Scores range from 0 to 36, with higher scores indicating greater emotional distress. Patient-Reported Outcomes Measurement Information System (PROMIS) Anger: 8-item scale which assesses anger. Scores range from 8 to 40, with higher scores indicating greater anger. Perceived Stress Scale: 10-item measure of general distress and perceived ability to cope. Scores range from 0 to 40, higher scores indicate greater stress.
Time frame: Baseline; 12 weeks
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization.
Patients documented all medical encounters on an annual basis after enrollment. Medical records were reviewed, and events, categorized on the basis of American College of Cardiology/American Heart Association criteria. The following medical events were included: all-cause mortality, fatal and nonfatal myocardial infarction (MI), coronary or peripheral artery revascularization, stroke/transient ischemic attack, and unstable angina requiring hospitalization.
Time frame: Baseline through Follow-up (median, 3.2 years)
Change in High-sensitivity C-Reactive Protein
High-sensitivity C-reactive protein was quantified by ELISA. Values \>10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker.
Time frame: Baseline; 12 weeks
Heart Rate Variability During Controlled Breathing (HRV-DB)
Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during a 100-second controlled breathing task.
Time frame: At 12 weeks
Baroreflex Sensitivity
Baroreflex sensitivity was obtained from beat-to-beat heart rate and blood pressure recorded from patients in the supine position with a Nexfin noninvasive blood pressure monitor.
Time frame: At 12 weeks
Heart Rate Variability During Rest
Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during 5 minutes of normal relaxed breathing
Time frame: At 12 weeks
Overall, 164 participants were consented for study participation. Of these, 151 participants were randomized to either Standard Cardiac Rehabilitation or SMT-Enhanced Cardiac Rehabilitation. Post-intervention assessments were completed on 145 participants; 151 participants were available for intention-to-treat analysis.
| Milestone | SMT-Enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Started | 76 | 75 |
| Completed | 73 | 72 |
| Not completed | 3 | 3 |
A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2.
| Mean rank score | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Absolute Composite Stress Score | 77.6 (71.5 to 83.7) | 67.5 (61.3 to 73.8) |
Beck Depression Inventory II: 21-item scale used to measure depression. Scores range from 0 to 63, with higher scores suggesting greater depressive symptoms. State-Trait Anxiety Inventory: 20-item scale which assess levels of state anxiety. Scores range from 20 to 80 with scores ≥40 suggesting clinically significant anxiety. General Health Questionnaire:12-item measure of general distress. Scores range from 0 to 36, with higher scores indicating greater emotional distress. Patient-Reported Outcomes Measurement Information System (PROMIS) Anger: 8-item scale which assesses anger. Scores range from 8 to 40, with higher scores indicating greater anger. Perceived Stress Scale: 10-item measure of general distress and perceived ability to cope. Scores range from 0 to 40, higher scores indicate greater stress.
| units on a scale | SMT-Enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Beck Depression Inventory-II | -3.5 (-5.0 to -2.1) | -2.6 (-4.1 to -1.2) |
| Spielberger Anxiety Inventory-State | -5.6 (-7.4 to -3.7) | -2.6 (-4.5 to -0.7) |
| General Health Questionnaire | -4.8 (-5.8 to -3.7) | -3.3 (-4.4 to -2.2) |
| PROMIS Anger Questionnaire | -2.0 (-3.0 to -1.0) | -1.0 (-2.1 to 0.0) |
| Perceived Stress Score | -4.2 (-5.4 to -3.0) | -2.6 (-3.9 to -1.3) |
Patients documented all medical encounters on an annual basis after enrollment. Medical records were reviewed, and events, categorized on the basis of American College of Cardiology/American Heart Association criteria. The following medical events were included: all-cause mortality, fatal and nonfatal myocardial infarction (MI), coronary or peripheral artery revascularization, stroke/transient ischemic attack, and unstable angina requiring hospitalization.
| Participants | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| All cause mortality | 0 | 2 |
| MI | 1 | 6 |
| Stent/CABG | 9 | 11 |
| Stroke/TIA | 1 | 1 |
| Peripheral Revascularization | 1 | 3 |
| Angina Requiring Hospitalization | 2 | 2 |
High-sensitivity C-reactive protein was quantified by ELISA. Values \>10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker.
| mg/L | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Change in High-sensitivity C-Reactive Protein | -0.9 (-1.4 to -0.5) | -0.4 (-0.9 to 0.0) |
Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during a 100-second controlled breathing task.
| ms | SMT-Enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Heart Rate Variability During Controlled Breathing (HRV-DB) | 13.1 (-8.0 to 34.3) | 26.0 (5.5 to 46.5) |
Baroreflex sensitivity was obtained from beat-to-beat heart rate and blood pressure recorded from patients in the supine position with a Nexfin noninvasive blood pressure monitor.
| ms/mm Hg | SMT-Enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Baroreflex Sensitivity | 0.47 (-0.39 to 1.33) | 0.93 (0.09 to 1.77) |
Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during 5 minutes of normal relaxed breathing
| ln (ms^2) | SMT-Enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation |
|---|---|---|
| Low-frequency | 0.17 (-0.08 to 0.27) | 0.28 (0.04 to 0.51) |
| High-frequency | 0.08 (-0.11 to 0.27) | 0.22 (0.03 to 0.41) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SMT-enhanced Cardiac Rehabilitation | — | 0/76 (0%) | 0/76 (0%) |
| Standard Cardiac Rehabilitation | — | 0/75 (0%) | 0/75 (0%) |
| Age, Continuous(years) | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation | Total |
|---|---|---|---|
| Mean | 61.8 ± 10.8 | 60.4 ± 10.6 | 61.0 ± 10.6 |
| Sex: Female, Male(Participants) | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation | Total |
|---|---|---|---|
| Female | 31 | 24 | 55 |
| Male | 45 | 51 | 96 |
| Race (NIH/OMB)(Participants) | SMT-enhanced Cardiac Rehabilitation | Standard Cardiac Rehabilitation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 23 | 40 |
| White | 58 | 51 | 109 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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