A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

NCT ID: NCT06695247

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-Based Exercise Training

Group Type: EXPERIMENTAL

Exercise Training

Intervention Type: OTHER

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)

Standard therapy (Standard of Care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Stan Henkin

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stan Henkin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stan Henkin, M.D.

Role: CONTACT

Henkin.Stanislav@mayo.edu

507-284-8612

Facility Contacts

Stan Henkin, M.D.

Role: primary

Henkin.Stanislav@mayo.edu

507-284-8612

Other Identifiers

24-009493

Identifier Type: -

Identifier Source: org_study_id