Recruiting

Home-Based Exercise

Sponsor:

Mayo Clinic

Code:

NCT06695247

Conditions

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Training

Study Details

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.

Conditions

Pulmonary Embolism

Study ID

NCT06695247

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-Based Exercise Training

no intervention: Standard therapy (Standard of Care)

Interventions

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 measure

  • Change in physical capacity from baseline [ Time Frame: Baseline, 3 Months, 6 Months ]

Central Contacts and Locations

Central contacts

Stan Henkin, M.D.

507-284-8612Henkin.Stanislav@mayo.edu

Locations

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Stan Henkin, M.D.

507-284-8612Henkin.Stanislav@mayo.edu

Principal Investigator:

Stan Henkin, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-10.