A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

NCT06695247 | Recruiting

• 1 other identifier: 24-009493
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in physical capacity from baseline

  Physical capacity will be determined by 6-minute walk distance (6MWD)

  Baseline, 3 Months, 6 Months

Secondary Outcomes (3)

• Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline

  Baseline, 3 Months, 6 Months

• Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline

  Baseline, 3 Months, 6 Months

• Number of Steps

  Baseline, 3 Months, 6 Months

Study Arms (2)

Home-Based Exercise Training

EXPERIMENTAL

Other: Exercise Training

Standard therapy (Standard of Care)

NO INTERVENTION

Interventions

Exercise Training OTHER

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)

Home-Based Exercise Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stan Henkin, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stan Henkin, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)