Clinical trial NCT00522340: Exercise After an ICD
Official title: Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Defibrillators, Implantable
Heart Failure, Congestive
Keywords: Implantable Cardioverter Defibrillators
ICD
Exercise
Cardiac
Inflammation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-08-29
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Cardiopulmonary function
timeFrame: Measured at Week 8
Secondary outcomes:
measure: Heart rate variability
timeFrame: Measured at Week 8
measure: Quality of life
timeFrame: Measured at Weeks 8 and 24
measure: Anxiety
timeFrame: Measured at Weeks 8 and 24
measure: Depression
timeFrame: Measured at Weeks 8 and 24
measure: Interleukin-6 (IL-6)
timeFrame: Measured at Weeks 8 and 24
measure: B-type natriuretic peptide (BNP)
timeFrame: Measured at Weeks 8 and 24
measure: ICD shocks
timeFrame: Measured at Weeks 8 and 24
measure: Tissue necrosis factor-alpha (TNF-alpha)
timeFrame: Measured at Weeks 8 and 24
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia Dougherty, ARNP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougherty CM, Burr RL, Kudenchuk PJ, Glenny RW. Aerobic Exercise Effects on Quality of Life and Psychological Distress After an Implantable Cardioverter Defibrillator. J Cardiopulm Rehabil Prev. 2020 Mar;40(2):94-101. doi: 10.1097/HCR.0000000000000444.
citation: Dougherty CM, Luttrell MN, Burr RL, Kim M, Haskell WL. Adherence to an Aerobic Exercise Intervention after an Implantable Cardioverter Defibrillator (ICD). Pacing Clin Electrophysiol. 2016 Feb;39(2):128-39. doi: 10.1111/pace.12782. Epub 2015 Dec 3.
citation: Dougherty CM, Glenny RW, Burr RL, Flo GL, Kudenchuk PJ. Prospective randomized trial of moderately strenuous aerobic exercise after an implantable cardioverter defibrillator. Circulation. 2015 May 26;131(21):1835-42. doi: 10.1161/CIRCULATIONAHA.114.014444. Epub 2015 Mar 19.
citation: 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.