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Clinical Trials/NCT06695247
NCT06695247RecruitingNot Applicable

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

Mayo Clinic1 site in 1 country100 target enrollmentStarted: July 14, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Change in physical capacity from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Home-Based Exercise Training

Experimental

Intervention: Exercise Training (Other)

Standard therapy (Standard of Care)

No Intervention

Outcomes

Primary Outcomes

Change in physical capacity from baseline

Time Frame: Baseline, 3 Months, 6 Months

Physical capacity will be determined by 6-minute walk distance (6MWD)

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stan Henkin

Associate Professor of Medicine

Mayo Clinic

Study Sites (1)

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