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临床试验/NCT00522340
NCT00522340已完成2 期

Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)

University of Washington1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年11月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Cardiopulmonary function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Aerobic Exercise Program

Experimental

干预措施: Aerobic Exercise Program (Behavioral)

Usual Care

No Intervention

结局指标

主要结局

Cardiopulmonary function

时间窗: Measured at Week 8

次要结局

  • Quality of life(Measured at Weeks 8 and 24)
  • Anxiety(Measured at Weeks 8 and 24)
  • B-type natriuretic peptide (BNP)(Measured at Weeks 8 and 24)
  • ICD shocks(Measured at Weeks 8 and 24)
  • Interleukin-6 (IL-6)(Measured at Weeks 8 and 24)
  • Heart rate variability(Measured at Week 8)
  • Depression(Measured at Weeks 8 and 24)
  • Tissue necrosis factor-alpha (TNF-alpha)(Measured at Weeks 8 and 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cindy Dougherty

Professor, Biobehavioral Nursing and Health Systems

University of Washington

研究点 (1)

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