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Stress Management and Biomarkers of Risk in Cardiac Rehabilitation (ENHANCED)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 22, 2009
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
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.

Condition Intervention
Coronary Heart Disease Behavioral: SMT-enhanced Cardiac Rehabilitation Behavioral: Standard Cardiac Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Standard Cardiac Rehabilitation With Stress Management Training in Patients With Heart Disease

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Stress Scores [ Time Frame: At 12 weeks ]

Secondary Outcome Measures:
  • Major Adverse Cardiovascular Events (MACE) - All cause death, MI, cardiac revascularization and cardiovascular hospitalization. [ Time Frame: At 12 weeks and at 6 and 12 month follow up and annually for up to 4 years post-treatment ]
  • Biomarkers [ Time Frame: At 12 weeks ]

Enrollment: 164
Study Start Date: September 2009
Study Completion Date: February 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMT-enhanced Cardiac Rehabilitation
Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.
Behavioral: SMT-enhanced Cardiac Rehabilitation
Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.
Active Comparator: Standard Cardiac Rehabilitation
Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.
Behavioral: Standard Cardiac Rehabilitation
Supervised exercise, three times per week, for 12 weeks.

Detailed Description:

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 < 30%
  • Labile ECG changes prior to testing
  • Currently using a pacemaker
  • Resting BP > 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981253

United States, North Carolina
University of North Carolina Hospitals - Meadowmont
Chapel Hill, North Carolina, United States, 27517
Duke University Medical Center - Center for Living
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James A. Blumenthal, PhD Duke University
Principal Investigator: Alan Hinderliter, MD University of North Carolina, Chapel Hill
  More Information

Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. Epub 2007 May 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00981253     History of Changes
Other Study ID Numbers: Pro00015896
R01HL093374-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 21, 2009
First Posted: September 22, 2009
Last Update Posted: December 4, 2017
Last Verified: March 2016

Keywords provided by Duke University:
Stress Management Training
Cardiac Rehabilitation

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases