Pulmonary Embolism
Conditions
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.
Interventions
OTHERExercise 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)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical capacity from baseline | Baseline, 3 Months, 6 Months | Physical capacity will be determined by 6-minute walk distance (6MWD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline | 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. |
| Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline | 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. |
| Number of Steps | Baseline, 3 Months, 6 Months | Number of Steps will be determined by fitbit tracking with Fitabase. |
Countries
United States
Contacts
CONTACTStan Henkin, M.D.
PRINCIPAL_INVESTIGATORStan Henkin, M.D.
Mayo Clinic
Outcome results
None listed