A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Other: Exercise Training

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stan Henkin, M.D.; Phone Number: 507-284-8612; Email: Henkin.Stanislav@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Stan Henkin, M.D.; Phone Number: 507-284-8612; Email: Henkin.Stanislav@mayo.edu
      • Principal Investigator: Stan Henkin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-Based Exercise Training	Other: 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)
No Intervention: Standard therapy (Standard of Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical capacity from baseline	Physical capacity will be determined by 6-minute walk distance (6MWD)	Baseline, 3 Months, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline	The Pulmonary Embolism-specific quality of life questionnaire assesses 6 quality of life dimensions in individuals with history of PE: frequency of symptoms, intensity of symptoms, activities of daily living limitations, social limitations, emotional distress, and work-related problems. Higher scores indicate worse quality of life.	Baseline, 3 Months, 6 Months
Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline	The Short Form 36 (SF-36) questionnaire assesses 8 quality of life dimensions: physical activity limitations, social activities limitations, activities of daily living physical limitations, bodily pain, general mental health, activities of daily living emotional limitations, vitality, and general health perceptions. Higher scores indicate better quality of life.	Baseline, 3 Months, 6 Months
Number of Steps	Number of Steps will be determined by fitbit tracking with Fitabase.	Baseline, 3 Months, 6 Months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stan Henkin, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: 24-009493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No