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Exercise After an ICD

Primary Purpose

Defibrillators, Implantable, Heart Failure, Congestive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Program
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Defibrillators, Implantable focused on measuring Implantable Cardioverter Defibrillators, ICD, Exercise, Cardiac, Inflammation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Exercise Program

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Cardiopulmonary function

Secondary Outcome Measures

Heart rate variability
Quality of life
Anxiety
Depression
Interleukin-6 (IL-6)
B-type natriuretic peptide (BNP)
ICD shocks
Tissue necrosis factor-alpha (TNF-alpha)

Full Information

First Posted
August 27, 2007
Last Updated
November 7, 2014
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00522340
Brief Title
Exercise After an ICD
Official Title
Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defibrillators, Implantable, Heart Failure, Congestive
Keywords
Implantable Cardioverter Defibrillators, ICD, Exercise, Cardiac, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Program
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Cardiopulmonary function
Time Frame
Measured at Week 8
Secondary Outcome Measure Information:
Title
Heart rate variability
Time Frame
Measured at Week 8
Title
Quality of life
Time Frame
Measured at Weeks 8 and 24
Title
Anxiety
Time Frame
Measured at Weeks 8 and 24
Title
Depression
Time Frame
Measured at Weeks 8 and 24
Title
Interleukin-6 (IL-6)
Time Frame
Measured at Weeks 8 and 24
Title
B-type natriuretic peptide (BNP)
Time Frame
Measured at Weeks 8 and 24
Title
ICD shocks
Time Frame
Measured at Weeks 8 and 24
Title
Tissue necrosis factor-alpha (TNF-alpha)
Time Frame
Measured at Weeks 8 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Dougherty, ARNP, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31397768
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.
Results Reference
derived
PubMed Identifier
26548341
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.
Results Reference
derived
PubMed Identifier
25792557
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.
Results Reference
derived
PubMed Identifier
22772084
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.
Results Reference
derived

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Exercise After an ICD

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