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Exercise After an ICD

NCT ID: NCT00522340

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Defibrillators, Implantable Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise Program

Group Type EXPERIMENTAL

Aerobic Exercise Program

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Cindy Dougherty

Professor, Biobehavioral Nursing and Health Systems

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Dougherty, ARNP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Dougherty CM, Cordoza M, Wang D, Alsoyan AH, Stein PK, Burr RL. Aerobic Exercise Improves Heart Rate Variability After an Implantable Cardioverter Defibrillator (ICD). Biol Res Nurs. 2024 Oct;26(4):584-596. doi: 10.1177/10998004241261273. Epub 2024 Jun 16.

Reference Type DERIVED
PMID: 38881252 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31397768 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26548341 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25792557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22772084 (View on PubMed)

Other Identifiers

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R01HL084550-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31202-B

Identifier Type: -

Identifier Source: org_study_id