Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 主要终点
- Model fit from repeated measures mixed model of heart rate/activity slope
研究概览
简要总结
The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.
详细描述
The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC < 0.7 and FEV1 < 80% predicted)
- •10 pack year smoking history
- •Hospitalized with one or more of:
- •increased dyspnea
- •increased sputum
- •change in sputum character
- •Treated with corticosteroids and/or antibiotics for respiratory indications
- •Age > 40 years old
排除标准
- •Discharging home on hospice
- •Inability to follow trial protocols
- •Allergy to a component of the adhesive patches
- •Breastfeeding
- •Permanent/continuous atrial fibrillation
结局指标
主要结局
Model fit from repeated measures mixed model of heart rate/activity slope
时间窗: 28 days
The investigators will average heart rate and activity (from accelerometer output) over 30-second periods. The highest 30-second average from each 5 minute period will be used to create the heart rate/activity slope for each 24-hour period while the device is worn. They will then model the change in heart rate/activity slope using a linear-mixed effect model with a random intercept and slope for each individual.
Heart rate variability slopes (time and frequency-domain)
时间窗: 28 days
The investigators will use Kubios software to calculate heart rate variability (time and frequency domain measurements) for each 24-hour period that the patch is worn. They will use repeated mixed measures models with random intercept and slope to model the change in heart rate variability after discharge.
次要结局
- Comparison of heart rate/activity slope in participants readmitted vs not-readmitted(28 days)
- Acceptability to participants(28 days)
- Comparison of heart rate variability slope in participants readmitted vs not-readmitted(28 days)
研究者
David MacDonald
Principal Investigator
Minneapolis Veterans Affairs Medical Center