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临床试验/NCT00680290
NCT00680290终止不适用

The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation.

研究概览

简要总结

The purpose of this study is to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation.

详细描述

  1. Twelve patients will be enrolled. Each subject will first serve as their own control and then serve in the treatment group. Subjects will be required to sign informed consent prior to any study procedure.
  2. The exercise program will be structured as follows:

At the time of enrollment, patients will undergo an exercise treadmill test to measure cardiac hemodynamics, including VO2max (measured non-invasively using gas exchange) and maximal heart rate. Average heart rate over 24 hours will also be measured by a 24-hour Holter monitor before and after the exercise program. The maximal exercise testing will be performed on a treadmill using an incremental protocol based on the estimated fitness level established during a warm up.

For the first 8-weeks of their participation, patients will act as their own control and not exercise. When the 8 week period is complete, they will return for another exercise treadmill test and 24-hour Holter monitor.

For the second 8-weeks of their participation, patients will participate in exercise training. The initial 2 weeks of exercise will be supervised at the St. Paul University Hospital exercise facility for twenty minutes a day, four times a week. Exercise will be done by walking or use of aerobic exercise equipment, which include a treadmill, elliptical machine, cycle ergometer or rowing machine according to patient preference and availability of exercise facilities at home.

During this period the patients will commence training at an intermediate effort based on perceived exertion (Borg Scale 11-13). The intensity will be gradually increased to a level corresponding to 70-75% VO2max or 15 on the Borg Scale, whichever represents the least effort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with permanent atrial fibrillation for at least three months duration, on stable medical therapy and in whom no additional interventions are planned to treat AF either due to clinical reasons or patient preferences
  • Have the ability to understand and sign consent to participate and be willing and able to comply with prescribed exercise and schedule of evaluations
  • Sedentary lifestyle as determined by Physical Activity Recall (PAR)
  • Be greater than 18 years of age

排除标准

  • Inability to exercise
  • Functional Class IV CHF symptoms
  • Active symptoms of angina, coronary artery disease
  • Patient with recent history of myocardial infarction
  • Patient with moderate or severely depressed left ventricular function (LVEF < 40 %)
  • Patient with any significant co-morbidities that may limit ability to exercise
  • Patients already engaged a structured exercise program

研究组 & 干预措施

1

Experimental

Exercise group

干预措施: Exercise (Procedure)

结局指标

主要结局

to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation.

时间窗: 8 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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