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Recruiting NCT06695247

A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

No phase Interventional Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Training.
Who it may be relevant to
Registry conditions: Pulmonary Embolism. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Change in physical capacity from baseline [Time frame: Baseline, 3 Months, 6 Months]
Secondary outcome measures (3)
  • Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline [Time frame: Baseline, 3 Months, 6 Months]
  • Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline [Time frame: Baseline, 3 Months, 6 Months]
  • Number of Steps [Time frame: Baseline, 3 Months, 6 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic Rochester — Rochester

Identifiers

NCT: NCT06695247 · 24-009493

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗