- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00522340
Exercise After an ICD
Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiopulmonary function
Time Frame: Measured at Week 8
|
Measured at Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate variability
Time Frame: Measured at Week 8
|
Measured at Week 8
|
Quality of life
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
Anxiety
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
Depression
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
Interleukin-6 (IL-6)
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
B-type natriuretic peptide (BNP)
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
ICD shocks
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
Tissue necrosis factor-alpha (TNF-alpha)
Time Frame: Measured at Weeks 8 and 24
|
Measured at Weeks 8 and 24
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31202-B
- R01HL084550-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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