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Exercise After an ICD

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cindy Dougherty, University of Washington
ClinicalTrials.gov Identifier:
NCT00522340
First received: August 27, 2007
Last updated: November 7, 2014
Last verified: November 2014

August 27, 2007
November 7, 2014
November 2007
June 2014   (final data collection date for primary outcome measure)
Cardiopulmonary function [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]
Cardiopulmonary function [ Time Frame: Measured at Week 8 ]
Complete list of historical versions of study NCT00522340 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Heart rate variability [ Time Frame: Measured at Week 8 ]
  • Quality of life [ Time Frame: Measured at Weeks 8 and 24 ]
  • Anxiety [ Time Frame: Measured at Weeks 8 and 24 ]
  • Depression [ Time Frame: Measured at Weeks 8 and 24 ]
  • Interleukin-6 (IL-6) [ Time Frame: Measured at Weeks 8 and 24 ]
  • B-type natriuretic peptide (BNP) [ Time Frame: Measured at Weeks 8 and 24 ]
  • ICD shocks [ Time Frame: Measured at Weeks 8 and 24 ]
  • Tissue necrosis factor-alpha (TNF-alpha) [ Time Frame: Measured at Weeks 8 and 24 ]
Not Provided
Not Provided
 
Exercise After an ICD
Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Defibrillators, Implantable
  • Heart Failure, Congestive
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.
  • Experimental: Aerobic Exercise Program
    Intervention: Behavioral: Aerobic Exercise Program
  • No Intervention: Usual Care
Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00522340
31202-B, R01HL084550-01A1, R01 HL084550-01A1
Yes
Cindy Dougherty, University of Washington
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Cynthia Dougherty, ARNP, PhD University of Washington
University of Washington
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP