Stress Management and Biomarkers of Risk in Cardiac Rehabilitation

NCT ID: NCT00981253

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-02-29

Brief 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.

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; 151 participants were available for intention-to-treat analysis.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMT-enhanced Cardiac Rehabilitation

Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.

Group Type: EXPERIMENTAL

SMT-enhanced Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Standard Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

Supervised exercise, three times per week, for 12 weeks.

Interventions

SMT-enhanced Cardiac Rehabilitation

Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks.

Intervention Type: BEHAVIORAL

Standard Cardiac Rehabilitation

Supervised exercise, three times per week, for 12 weeks.

Intervention Type: BEHAVIORAL

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 < 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A. Blumenthal, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Alan Hinderliter, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Hospitals - Meadowmont

Chapel Hill, North Carolina, United States

Duke University Medical Center - Center for Living

Durham, North Carolina, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 15106183 (View on PubMed)

Jones DA, West RR. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial. BMJ. 1996 Dec 14;313(7071):1517-21. doi: 10.1136/bmj.313.7071.1517.

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Reference Type: BACKGROUND

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Blumenthal JA, Babyak M, Wei J, O'Connor C, Waugh R, Eisenstein E, Mark D, Sherwood A, Woodley PS, Irwin RJ, Reed G. Usefulness of psychosocial treatment of mental stress-induced myocardial ischemia in men. Am J Cardiol. 2002 Jan 15;89(2):164-8. doi: 10.1016/s0002-9149(01)02194-4.

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Blumenthal JA, Sherwood A, Babyak MA, Watkins LL, Waugh R, Georgiades A, Bacon SL, Hayano J, Coleman RE, Hinderliter A. Effects of exercise and stress management training on markers of cardiovascular risk in patients with ischemic heart disease: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1626-34. doi: 10.1001/jama.293.13.1626.

Reference Type: BACKGROUND

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Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.

Reference Type: DERIVED

PMID: 27045127 (View on PubMed)

Other Identifiers

R01HL093374-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00015896

Identifier Type: -

Identifier Source: org_study_id