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Defibrillators, ImplantablePhase 2NCT00522340

Exercise After an ICD

A Phase 2 study testing Aerobic Exercise Program in people with Defibrillators, Implantable and Heart Failure, Congestive, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Aerobic Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
Nov 2007to Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ICD implanted in the 12 months prior to study entry
  • Currently taking beta blocker medication
  • Speaks and reads English

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Aerobic Exercise Program
Keywords
Implantable Cardioverter Defibrillators, ICD, Exercise, Cardiac, Inflammation
Medical subject headings
Heart Failure, Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic Exercise ProgramBehavioural

    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.

Study groups in NCT00522340
Study groupRoleWhat they receive
Aerobic Exercise ProgramExperimentalNot described
Receives: Behavioral: Aerobic Exercise Program
Usual CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiopulmonary function

    Measured: Measured at Week 8

Secondary outcomes (8)

  1. Heart rate variability

    Measured: Measured at Week 8

  2. Quality of life

    Measured: Measured at Weeks 8 and 24

  3. Anxiety

    Measured: Measured at Weeks 8 and 24

  4. Depression

    Measured: Measured at Weeks 8 and 24

  5. Interleukin-6 (IL-6)

    Measured: Measured at Weeks 8 and 24

  6. B-type natriuretic peptide (BNP)

    Measured: Measured at Weeks 8 and 24

  7. ICD shocks

    Measured: Measured at Weeks 8 and 24

  8. Tissue necrosis factor-alpha (TNF-alpha)

    Measured: Measured at Weeks 8 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522340
Sponsor's protocol ID
31202-B
Other IDs
R01HL084550-01A1
Status last verified
Nov 2014
First submitted
27 Aug 2007
Last updated
10 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38881252

  • 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.

    PubMed 31397768

  • 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.

    PubMed 26548341

  • 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.

    PubMed 25792557

  • 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.

    PubMed 22772084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aerobic Exercise Program in people with Defibrillators, Implantable and Heart Failure, Congestive, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary function (time frame: Measured at Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522340, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.

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