A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

Официальное название

Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized Trial

Обзор

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.

Вмешательства

• Другое Exercise Training
  Patients will be recommended to exercise 3 days/week, 20 minutes per session, for 12 weeks using personalized intervention determined by a consultation with a clinical exercise physiologist (CEP)

Первичные конечные точки

• Change in physical capacity from baseline [Срок оценки: Baseline, 3 Months, 6 Months]

Вторичные конечные точки (3)

• Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline [Срок оценки: Baseline, 3 Months, 6 Months]
• Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline [Срок оценки: Baseline, 3 Months, 6 Months]
• Number of Steps [Срок оценки: Baseline, 3 Months, 6 Months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic Rochester — Rochester

Идентификаторы

NCT: NCT06695247 · 24-009493

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗