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