NCT06695247招募中不适用
Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in physical capacity from baseline
研究概览
简要总结
The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute intermediate-risk PE, defined as:
- •Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
- •Evidence of right ventricular enlargement by computed tomography (RV to LV ratio >1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition.
- •Acute high-risk PE, defined as:
- •Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
- •Evidence of right ventricular enlargement by computed tomography (RV to LV ratio >1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition; AND
- •Hypotension (systolic blood pressure < 90 mm Hg sustained for more than 15 minutes; or requiring vasopressors) or cardiogenic shock due to acute pulmonary embolism.
排除标准
- •Inability to ambulate independently, which is necessary to perform 6MWD (may be self-reported or as deemed by physical therapy during inpatient evaluation).
- •If patient requires supplemental oxygen during ambulation, this does not exclude patient from participation and will be noted during eCRF.
- •Prior history of pulmonary embolism
- •History of CTEPH or pulmonary arterial hypertension
- •Unable to read a questionnaire in English
- •Unable to return for baseline, 3- or 6-month follow-up visit
- •Pregnancy-associated pulmonary embolism
- •Life expectancy <1 year based on comorbidities
- •Unable/unwilling to provide informed written consent
研究组 & 干预措施
Home-Based Exercise Training
Experimental
干预措施: Exercise Training (Other)
Standard therapy (Standard of Care)
No Intervention
结局指标
主要结局
Change in physical capacity from baseline
时间窗: Baseline, 3 Months, 6 Months
Physical capacity will be determined by 6-minute walk distance (6MWD)
次要结局
- Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline(Baseline, 3 Months, 6 Months)
- Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline(Baseline, 3 Months, 6 Months)
- Number of Steps(Baseline, 3 Months, 6 Months)
研究者
Stan Henkin
Associate Professor of Medicine
Mayo Clinic
研究点 (1)
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