Home Rehabilitation After Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- mean change in vector magnitude count as measured by actigraphy
研究概览
简要总结
The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking (>18 years old). Daily messages will be sent in English.
- •Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin).
- •Baseline testing started within 7 days of hospital discharge.
排除标准
- •Pregnancy.
- •Cardiac Effort >2.5 beats/m during 6MWT. This is for safety.
- •Cardiac Effort <1.2 beats/m during 6MWT. They are unlikely to benefit.
- •Resting tachycardia >120 beats/m during screening or at hospital discharge.
- •Suspicion for Chronic Thromboembolic Pulmonary Hypertension.
- •Systolic blood pressure >180 mmHg during screening or at hospital discharge.
- •Inability to walk.
- •Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities.
- •Advanced neurologic disease.
- •Lack of access to email or text messaging.
- •Inability to follow daily instructions.
- •Participation in a structured exercise routine at least three days per week in the prior four weeks.
- •Principal Investigator discretion
结局指标
主要结局
mean change in vector magnitude count as measured by actigraphy
时间窗: 10 weeks
The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the vector magnitude count.
mean change in mean amplitude deviation as measured by actigraphy
时间窗: 10 weeks
The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the mean amplitude deviation.
次要结局
- mean change in 6 minute walking distance(12 weeks)
- mean change in oxygen use during a 6 minute walk(12 weeks)
- mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire(12 weeks)
- mean change in carbon dioxide production during a 6 minute walk(12 weeks)
- mean change in quality of life as measured by PROMIS(12 weeks)
- proportion of participants with post-PE syndrome(12 weeks)
- mean change in steps as measured by Actigraph(12 weeks)
- mean change in activity as measured by Actigraph(12 weeks)
- mean change in quality of life as measured by Emphasis 10(12 weeks)
- mean change in heart rate during a 6 minute walk(12 weeks)
- proportion or subjects who develop chronic thromboembolic pulmonary hypertension(12 weeks)
研究者
Daniel Lachant
Assistant Professor
University of Rochester