Trial Outcomes & Findings for Stress Management and Biomarkers of Risk in Cardiac Rehabilitation (NCT NCT00981253)

NCT ID: NCT00981253

Last Updated: 2018-02-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 164 participants
• Primary outcome timeframe: Baseline; 12 weeks
• Results posted on: 2018-02-01

Participant Flow

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.

Participant milestones

Measure	SMT-Enhanced Cardiac Rehabilitation Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Overall Study STARTED	76	75
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stress Management and Biomarkers of Risk in Cardiac Rehabilitation

Baseline characteristics by cohort

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.	Total n=151 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	60.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	61.0 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	51 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	23 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	51 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; 12 weeks

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Absolute Composite Stress Score	77.6 Mean rank score Interval 71.5 to 83.7	67.5 Mean rank score Interval 61.3 to 73.8

PRIMARY outcome

Timeframe: Baseline; 12 weeks

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Change From Baseline to 12 Weeks in Individual Scaled Scores PROMIS Anger Questionnaire	-2.0 units on a scale Interval -3.0 to -1.0	-1.0 units on a scale Interval -2.1 to 0.0
Change From Baseline to 12 Weeks in Individual Scaled Scores Perceived Stress Score	-4.2 units on a scale Interval -5.4 to -3.0	-2.6 units on a scale Interval -3.9 to -1.3
Change From Baseline to 12 Weeks in Individual Scaled Scores Beck Depression Inventory-II	-3.5 units on a scale Interval -5.0 to -2.1	-2.6 units on a scale Interval -4.1 to -1.2
Change From Baseline to 12 Weeks in Individual Scaled Scores Spielberger Anxiety Inventory-State	-5.6 units on a scale Interval -7.4 to -3.7	-2.6 units on a scale Interval -4.5 to -0.7
Change From Baseline to 12 Weeks in Individual Scaled Scores General Health Questionnaire	-4.8 units on a scale Interval -5.8 to -3.7	-3.3 units on a scale Interval -4.4 to -2.2

SECONDARY outcome

Timeframe: Baseline through Follow-up (median, 3.2 years)

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. All cause mortality	0 Participants	2 Participants
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. MI	1 Participants	6 Participants
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. Stent/CABG	9 Participants	11 Participants
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. Stroke/TIA	1 Participants	1 Participants
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. Peripheral Revascularization	1 Participants	3 Participants
Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization. Angina Requiring Hospitalization	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline; 12 weeks

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Change in High-sensitivity C-Reactive Protein	-0.9 mg/L Interval -1.4 to -0.5	-0.4 mg/L Interval -0.9 to 0.0

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Heart Rate Variability During Controlled Breathing (HRV-DB)	13.1 ms Interval -8.0 to 34.3	26.0 ms Interval 5.5 to 46.5

SECONDARY outcome

Timeframe: At 12 weeks

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.

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Baroreflex Sensitivity	0.47 ms/mm Hg Interval -0.39 to 1.33	0.93 ms/mm Hg Interval 0.09 to 1.77

SECONDARY outcome

Timeframe: At 12 weeks

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

Outcome measures

Measure	SMT-enhanced Cardiac Rehabilitation n=76 Participants Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks. SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.	Standard Cardiac Rehabilitation n=75 Participants Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks. Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks.
Heart Rate Variability During Rest Low-frequency	0.17 ln (ms^2) Interval -0.08 to 0.27	0.28 ln (ms^2) Interval 0.04 to 0.51
Heart Rate Variability During Rest High-frequency	0.08 ln (ms^2) Interval -0.11 to 0.27	0.22 ln (ms^2) Interval 0.03 to 0.41

Adverse Events

SMT-enhanced Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James A. Blumenthal

Duke Health

Phone: 919-684-3828

Email: james.blumenthal@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place