Status:
COMPLETED
Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure
Lead Sponsor:
University of Kentucky
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effect of biofeedback-relaxation combined with cognitive behavioral therapy on clinical, physical and psychological outcomes in patients with heart failur...
Detailed Description
The long-term aim of this program of research is to improve physical and psychological health outcomes of adults with heart failure (HF). The specific aims of the randomized, controlled clinical trial...
Eligibility Criteria
Inclusion
- confirmed diagnosis of chronic advanced HF. Other sample selection criteria include: 1) on stable doses of HF medication for at least one month; and 2) not referred for heart transplantation.
Exclusion
- Patients will be excluded if they have: 1) valvular heart disease (as a primary cause of their HF; can have it if the primary cause is ischemic, hypertensive or idiopathic), peripartum heart failure, myocarditis; 2) history of cerebral vascular accident (CVA) within previous 3 months or major stroke sequelae; 3) history of major extremity vascular problems; 4) recent (within 3 months) myocardial infarction (MI); 5) coexisting terminal illness; 6) systolic blood pressure less than 80 mmHg; or 7) previous experience with biofeedback, relaxation .
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00255931
Start Date
July 1 2004
End Date
May 1 2010
Last Update
June 5 2012
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40535