Stress Management and Biomarkers of Risk in Cardiac Rehabilitation

NCT00981253 | Completed Results DMC

• 2 other identifiers: Pro00015896R01HL093374-01A2
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Heart Disease

Keywords

Stress Management Training; Cardiac Rehabilitation; Stress; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline; 12 weeks

Secondary Outcomes (5)

• Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization.

  Baseline through Follow-up (median, 3.2 years)

• Change in High-sensitivity C-Reactive Protein

  Baseline; 12 weeks

• Heart Rate Variability During Controlled Breathing (HRV-DB)

  At 12 weeks

• Baroreflex Sensitivity

  At 12 weeks

• Heart Rate Variability During Rest

  At 12 weeks

Study Arms (2)

SMT-enhanced Cardiac Rehabilitation

EXPERIMENTAL

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

Behavioral: SMT-enhanced Cardiac Rehabilitation

Standard Cardiac Rehabilitation

ACTIVE COMPARATOR

Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.

Behavioral: Standard Cardiac Rehabilitation

Interventions

SMT-enhanced Cardiac Rehabilitation BEHAVIORAL

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

SMT-enhanced Cardiac Rehabilitation

Standard Cardiac Rehabilitation BEHAVIORAL

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

Standard Cardiac Rehabilitation

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Coronary Heart Disease (CHD)
• Eligibility for Cardiac Rehabilitation (CR) in North Carolina
• Capacity to give informed consent and follow study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of North Carolina Hospitals - Meadowmont

Chapel Hill, North Carolina, 27517, United States

Location

Duke University Medical Center - Center for Living

Durham, North Carolina, 27710, United States

Location

Related Publications (10)

• Blumenthal JA, Jiang W, Babyak MA, Krantz DS, Frid DJ, Coleman RE, Waugh R, Hanson M, Appelbaum M, O'Connor C, Morris JJ. Stress management and exercise training in cardiac patients with myocardial ischemia. Effects on prognosis and evaluation of mechanisms. Arch Intern Med. 1997 Oct 27;157(19):2213-23.

  PMID: 9342998 BACKGROUND

• Rees K, Bennett P, West R, Davey SG, Ebrahim S. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev. 2004;(2):CD002902. doi: 10.1002/14651858.CD002902.pub2.

  PMID: 15106183 BACKGROUND

• 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.

  PMID: 8978226 BACKGROUND

• Frasure-Smith N, Lesperance F, Prince RH, Verrier P, Garber RA, Juneau M, Wolfson C, Bourassa MG. Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction. Lancet. 1997 Aug 16;350(9076):473-9. doi: 10.1016/S0140-6736(97)02142-9.

  PMID: 9274583 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.106.180945. Epub 2007 May 18.

  PMID: 17513578 BACKGROUND

• Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001 Sep 20;345(12):892-902. doi: 10.1056/NEJMra001529. No abstract available.

  PMID: 11565523 BACKGROUND

• Wenger NK, Froelicher ES, Smith LK, Ades PA, Berra K, Blumenthal JA, Certo CM, Dattilo AM, Davis D, DeBusk RF, et al. Cardiac rehabilitation as secondary prevention. Agency for Health Care Policy and Research and National Heart, Lung, and Blood Institute. Clin Pract Guidel Quick Ref Guide Clin. 1995 Oct;(17):1-23.

  PMID: 8595435 BACKGROUND

• 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.

  PMID: 11792336 BACKGROUND

• 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.

  PMID: 15811982 BACKGROUND

• 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.

  PMID: 27045127 DERIVED

MeSH Terms

Conditions

Coronary Disease; Depression

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

Comparison group was not randomized to non-CR; relatively small sample and few 'hard' end points over the follow-up period.

Results Point of Contact

• Title: Dr. James A. Blumenthal
• Organization: Duke Health

james.blumenthal@duke.edu

919-684-3828

Study Officials

• James A. Blumenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Alan Hinderliter, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: February 1, 2016
• Last Updated: February 1, 2018
• Results First Posted: January 5, 2018

Record last verified: 2018-01

Locations

US (2)