Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00522340
Other study ID # 31202-B
Secondary ID R01HL084550-01A1
Status Completed
Phase Phase 2
First received August 27, 2007
Last updated November 7, 2014
Start date November 2007
Est. completion date June 2014

Study information

Verified date November 2014
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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. This study will examine the effects of an exercise program on heart and lung function in people who have an ICD.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiopulmonary function Measured at Week 8 Yes
Secondary Heart rate variability Measured at Week 8 No
Secondary Quality of life Measured at Weeks 8 and 24 No
Secondary Anxiety Measured at Weeks 8 and 24 No
Secondary Depression Measured at Weeks 8 and 24 No
Secondary Interleukin-6 (IL-6) Measured at Weeks 8 and 24 No
Secondary B-type natriuretic peptide (BNP) Measured at Weeks 8 and 24 No
Secondary ICD shocks Measured at Weeks 8 and 24 Yes
Secondary Tissue necrosis factor-alpha (TNF-alpha) Measured at Weeks 8 and 24 No
See also
  Status Clinical Trial Phase
Completed NCT01357850 - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure Phase 2
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Terminated NCT00383630 - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure Phase 2
Completed NCT00531661 - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients N/A
Terminated NCT00125437 - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy N/A
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Completed NCT00241761 - Epidemiology of Depression and Heart Failure in Aging N/A
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study
Completed NCT00094263 - Long-Term Predictors of Morbidity in Older Age N/A
Completed NCT00202579 - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure Phase 2
Terminated NCT00357591 - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation N/A
Completed NCT00048425 - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. Phase 3
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Completed NCT00530426 - Heart Failure Registry Phase 4
Terminated NCT00190359 - Growth Hormone and Heart Failure N/A
Completed NCT00004562 - Occluded Artery Trial (OAT) Phase 3
Completed NCT00005265 - Natural History of Coronary Heart Disease N/A
Completed NCT02772068 - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Early Phase 1
Completed NCT02925546 - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets Phase 1
Completed NCT01074307 - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea Phase 4