Effectiveness of an Exercise Program at Improving Heart and Lung Function in People With an Implantable Cardioverter Defibrillator (ICD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00522340
First received: August 27, 2007
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Defibrillators, Implantable
Heart Failure, Congestive
Behavioral: Aerobic Exercise Program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Cardiopulmonary function [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]
  • Interleukin-6 (IL-6) [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]
  • B-type natriuretic peptide (BNP) [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]
  • ICD shocks [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: Yes ]
  • Tissue necrosis factor-alpha (TNF-alpha) [ Time Frame: Measured at Weeks 8 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: November 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exercise Program 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.
No Intervention: Usual Care

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522340

Contacts
Contact: Cynthia Dougherty, ARNP, PhD 206-221-7927 cindyd@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Cynthia Dougherty, ARNP, PhD    206-221-7927    cindyd@u.washington.edu   
Principal Investigator: Cynthia Dougherty, ARNP, PhD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Cynthia Dougherty, ARNP, PhD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00522340     History of Changes
Other Study ID Numbers: 510, R01HL084550-01A1, R01 HL084550-01A1
Study First Received: August 27, 2007
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Implantable Cardioverter Defibrillators
ICD
Exercise
Cardiac
Inflammation

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014