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Exercise After an ICD

Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522340
Enrollment
160
Registered
2007-08-29
Start date
2007-11-30
Completion date
2014-06-30
Last updated
2014-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillators, Implantable, Heart Failure, Congestive

Keywords

Implantable Cardioverter Defibrillators, ICD, Exercise, Cardiac, Inflammation

Brief summary

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.

Detailed description

An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening rhythm. People who have experienced ventricular fibrillation, which is a severely abnormal heart rhythm, or ventricular tachycardia, which is a rapid heart beat that begins in the bottom chambers of the heart, are common recipients of an ICD. Other potential ICD recipients include people who have survived a heart attack, but have weak hearts; people with heart muscle problems; and people with reduced pumping function in their heart. People who have ICDs may benefit from aerobic exercise to improve their physical fitness and overall health. The purpose of this study is to evaluate the effectiveness of an exercise program at improving heart and lung function in people who have an ICD. In this 6-month study, participants will be randomly assigned to either take part in the exercise program or receive usual care. At a baseline study visit, all participants will complete an exercise treadmill test, wear a Holter monitor to record heart activity for 24 hours, undergo blood collection, and complete questionnaires to assess quality of life, anxiety, and depression. Participants taking part in the exercise program will receive 1 hour of exercise education over the telephone. During Weeks 1 through 8, participants will stretch for 10 minutes and walk 1 hour daily for 5 days a week; during Weeks 9 through 24, participants will walk 30 minutes daily for 5 days a week. Participants will wear a Polar Heart Rate monitor to record their heart rate and a pedometer to keep track of the number of steps walked. They will also record details of their exercise in a daily activity log. Throughout the entire study, a study nurse will call participants on a weekly basis to check on their progress and to help resolve any exercise-related problems. At Weeks 8 and 24, all participants including those receiving usual care, will attend a study visit for repeat baseline evaluations. Study researchers will review medical records to collect various information, including the reason for needing an ICD, the type and settings of the ICD, medication use, medical history, current health problems, lab test results, echocardiogram images of the heart, and electrocardiogram (EKG) results.

Interventions

Home walking 1 hour a day for 5 days/week for 8 weeks. Then 30 minutes a day on all or most days of the week.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cardiopulmonary functionMeasured at Week 8

Secondary

MeasureTime frame
Quality of lifeMeasured at Weeks 8 and 24
AnxietyMeasured at Weeks 8 and 24
DepressionMeasured at Weeks 8 and 24
Heart rate variabilityMeasured at Week 8
B-type natriuretic peptide (BNP)Measured at Weeks 8 and 24
ICD shocksMeasured at Weeks 8 and 24
Tissue necrosis factor-alpha (TNF-alpha)Measured at Weeks 8 and 24
Interleukin-6 (IL-6)Measured at Weeks 8 and 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026