Home-based exercise program for patients with pulmonary embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve mobility outcomes for patients recovering from pulmonary embolism by implementing a home-based exercise program. The program is designed through the collaboration of cardiovascular medicine specialists and cardiac physiologists, utilizing an Interactive Care Plan to guide patients in their rehabilitation. Participants will engage in structured exercise training tailored to their specific needs and conditions. The study focuses on patients with acute intermediate-risk and high-risk pulmonary embolism, as identified through imaging techniques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

* 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

Where it's running

• Mayo Clinic Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Stan Henkin, M.D. — Mayo Clinic
• Study coordinator: Stan Henkin, M.D.
• Email: Henkin.Stanislav@mayo.edu
• Phone: 507-284-8612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.