Home-based exercise program for patients with pulmonary embolism
Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized Trial
This study is testing a home-based exercise program to help people recovering from pulmonary embolism improve their mobility and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06695247 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with acute intermediate-risk or high-risk pulmonary embolism who exhibit specific imaging characteristics.
Not a fit: Patients with chronic pulmonary conditions or those not meeting the acute pulmonary embolism criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance recovery and mobility for patients suffering from pulmonary embolism.
How similar studies have performed: Other studies have shown positive outcomes with home-based exercise interventions for similar conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.