Heart Failure, Congestive Clinical Trial
Official title:
Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Verified date | November 2014 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
An implantable cardioverter-defibrillator (ICD) is a small device that is surgically implanted in the chest or abdomen and uses electrical pulses or shocks to help control life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health benefits to people with ICDs. This study will examine the effects of an exercise program on heart and lung function in people who have an ICD.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - ICD implanted in the 12 months prior to study entry - Currently taking beta blocker medication - Speaks and reads English Exclusion Criteria: - Unstable angina, heart attack, or percutaneous coronary intervention (PCI) in the 3 months prior to study entry - Experienced an ICD shock in the 3 months prior to study entry - Currently exercises 3 times a week for 20 minutes a day - Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score for alcohol consumption greater than 4 - Shore Blessed score for cognitive dysfunction greater than 6 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiopulmonary function | Measured at Week 8 | Yes | |
Secondary | Heart rate variability | Measured at Week 8 | No | |
Secondary | Quality of life | Measured at Weeks 8 and 24 | No | |
Secondary | Anxiety | Measured at Weeks 8 and 24 | No | |
Secondary | Depression | Measured at Weeks 8 and 24 | No | |
Secondary | Interleukin-6 (IL-6) | Measured at Weeks 8 and 24 | No | |
Secondary | B-type natriuretic peptide (BNP) | Measured at Weeks 8 and 24 | No | |
Secondary | ICD shocks | Measured at Weeks 8 and 24 | Yes | |
Secondary | Tissue necrosis factor-alpha (TNF-alpha) | Measured at Weeks 8 and 24 | No |
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