Pulmonary EmbolismNCT06695247
A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
A study testing Exercise Training in people with Pulmonary Embolism, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy-associated pulmonary embolism
- Life expectancy <1 year based on comorbidities
- Unable/unwilling to provide informed written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Stan Henkin, M.D., 507-284-8612, Henkin.Stanislav@mayo.edu
Stan Henkin, M.D.
About this study
Official title: Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Exercise Training
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Exercise Training | Experimental | Not described Receives: Other: Exercise Training |
| Standard therapy (Standard of Care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical capacity from baseline
Physical capacity will be determined by 6-minute walk distance (6MWD)
Measured: Baseline, 3 Months, 6 Months
Secondary outcomes (3)
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.
Measured: Baseline, 3 Months, 6 Months
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.
Measured: Baseline, 3 Months, 6 Months
Number of Steps
Number of Steps will be determined by fitbit tracking with Fitabase.
Measured: Baseline, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start14 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stan Henkin, Mayo Clinic
- Investigators
- Stan Henkin, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695247
- Sponsor's protocol ID
- 24-009493
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06695247
- Acronym / sponsor ID
- 24-009493
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-Based Exercise Training | Experimental | Other: Exercise Training |
| Standard therapy (Standard of Care) | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Hypotension (systolic blood pressure < 90 mm Hg sustained for more than 15 minutes; or requiring vasopressors) or cardiogenic shock due to acute pulmonary embolism.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingPatients 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) | Other | Home-Based Exercise Training |
Primary outcome
Change in physical capacity from baseline
Time frame: Baseline, 3 Months, 6 Months
Physical capacity will be determined by 6-minute walk distance (6MWD)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stan Henkin, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Pulmonary Embolism, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stan Henkin, M.D. (507-284-8612, Henkin.Stanislav@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical capacity from baseline (time frame: Baseline, 3 Months, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.