A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Training
Other interventionPatients 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)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Home-Based Exercise TrainingExperimental treatment 1 intervention
Group B: Standard therapy (Standard of Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in physical capacity from baseline
Physical capacity will be determined by 6-minute walk distance (6MWD)
Time frame
Baseline, 3 Months, 6 MonthsSecondary outcomes
1
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.
Time frame
Baseline, 3 Months, 6 Months2
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.
Time frame
Baseline, 3 Months, 6 Months3
Number of Steps
Number of Steps will be determined by fitbit tracking with Fitabase.
Time frame
Baseline, 3 Months, 6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov