Skip to main content
OpenTrials
Completed

NCT Number: NCT00522340

Exercise After an ICD

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Program

Behavioral

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.

Primary outcomes

  1. Cardiopulmonary function

    Time frame: Measured at Week 8

Secondary outcomes

  1. Heart rate variability

    Time frame: Measured at Week 8

  2. Quality of life

    Time frame: Measured at Weeks 8 and 24

  3. Anxiety

    Time frame: Measured at Weeks 8 and 24

  4. Depression

    Time frame: Measured at Weeks 8 and 24

  5. Interleukin-6 (IL-6)

    Time frame: Measured at Weeks 8 and 24

  6. B-type natriuretic peptide (BNP)

    Time frame: Measured at Weeks 8 and 24

  7. ICD shocks

    Time frame: Measured at Weeks 8 and 24

  8. Tissue necrosis factor-alpha (TNF-alpha)

    Time frame: Measured at Weeks 8 and 24

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2007
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.