Exercise After an ICD

Phase 2

Completed

• Conditions: Heart Failure, Congestive; Defibrillators, Implantable
• Interventions: Behavioral: Aerobic Exercise Program

• Registration Number: NCT00522340
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-29
• Study Start: 2007-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• ICD implanted in the 12 months prior to study entry
• Currently taking beta blocker medication
• Speaks and reads English

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Program	Aerobic Exercise Program	-

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary function	Measured at Week 8

Secondary Outcome Measures

Name	Time	Method
Quality of life	Measured at Weeks 8 and 24
Anxiety	Measured at Weeks 8 and 24
ICD shocks	Measured at Weeks 8 and 24
B-type natriuretic peptide (BNP)	Measured at Weeks 8 and 24
Interleukin-6 (IL-6)	Measured at Weeks 8 and 24
Heart rate variability	Measured at Week 8
Depression	Measured at Weeks 8 and 24
Tissue necrosis factor-alpha (TNF-alpha)	Measured at Weeks 8 and 24

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States