Exercise After an ICD

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522340
• Other study ID #: 31202-B
• Secondary ID: R01HL084550-01A1
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2007
• Last updated: November 7, 2014
• Start date: November 2007
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Defibrillators, Implantable
• Heart Failure
• Heart Failure, Congestive

Intervention

Behavioral:
• Aerobic Exercise Program
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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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