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NCT Number: NCT06695247

A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Stan Henkin, M.D.

CONTACT

[email protected]

507-284-8612

Stan Henkin, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

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)

Primary outcomes

  1. 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

  1. Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline

    Time frame: Baseline, 3 Months, 6 Months

    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.

  2. Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline

    Time frame: Baseline, 3 Months, 6 Months

    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.

  3. Number of Steps

    Time frame: Baseline, 3 Months, 6 Months

    Number of Steps will be determined by fitbit tracking with Fitabase.

Study contacts

Contact information is provided by the study sponsor or research team.

Stan Henkin, M.D.

CONTACT

[email protected]

507-284-8612

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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