Trial record 2 of 32 for:    cardiac rehabilitation | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants.
Verified February 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00981253
First received: September 21, 2009
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 and Biomarker Global Scores [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, death and cardiac hospitalizations. [ Time Frame: At 12 weeks and at 6 and 12 month follow up and annually for up to 4 years post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 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 medical events and medication use.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981253

Contacts
Contact: James A. Blumenthal, PhD 919-684-3828 blume003@duke.edu
Contact: Stephanie K. Mabe, MS 919-668-3555 stephanie.mabe@duke.edu

Locations
United States, North Carolina
University of North Carolina Hospitals - Meadowmont Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Alan Hinderliter, MD    919-216-3686    hinderli@med.unc.edu   
Sub-Investigator: Paula Miller, MD         
Duke University Medical Center - Center for Living Recruiting
Durham, North Carolina, United States, 27710
Contact: James A. Blumenthal, PhD    919-684-3828    blume003@duke.edu   
Contact: Stephanie K. Mabe, MS    919-668-3555    stephanie.mabe@duke.edu   
Sub-Investigator: Andrew Sherwood, PhD         
Sub-Investigator: Michael A. Babyak, PhD         
Sub-Investigator: Lana Watkins, PhD         
Sub-Investigator: William E. Kraus, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A. Blumenthal, PhD Duke University
Principal Investigator: Alan Hinderliter, MD University of North Carolina, Chapel Hill
  More Information

Publications:
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.

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00981253     History of Changes
Other Study ID Numbers: Pro00015896, R01HL093374-01A2, R01 HL093374-01A2
Study First Received: September 21, 2009
Last Updated: February 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
Stress Management Training
Cardiac Rehabilitation
Stress
Depression

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

ClinicalTrials.gov processed this record on April 17, 2014