NCT00522340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

6.6 years

First QC Date

August 27, 2007

Last Update Submit

November 7, 2014

Conditions

Defibrillators, ImplantableHeart Failure, Congestive

Keywords

Implantable Cardioverter DefibrillatorsICDExerciseCardiacInflammation

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary function

    Measured at Week 8

Secondary Outcomes (8)

  • Heart rate variability

    Measured at Week 8

  • Quality of life

    Measured at Weeks 8 and 24

  • Anxiety

    Measured at Weeks 8 and 24

  • Depression

    Measured at Weeks 8 and 24

  • Interleukin-6 (IL-6)

    Measured at Weeks 8 and 24

  • +3 more secondary outcomes

Study Arms (2)

Aerobic Exercise Program

EXPERIMENTAL
Behavioral: Aerobic Exercise Program

Usual Care

NO INTERVENTION

Interventions

Aerobic Exercise ProgramBEHAVIORAL

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.

Aerobic Exercise Program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (5)

  • 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.

    PMID: 38881252DERIVED

  • 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.

    PMID: 31397768DERIVED

  • 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.

    PMID: 26548341DERIVED

  • 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.

    PMID: 25792557DERIVED

  • 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.

    PMID: 22772084DERIVED

MeSH Terms

Conditions

Heart FailureMotor ActivityInflammation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Dougherty, ARNP, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Biobehavioral Nursing and Health Systems

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(1)