Healthy living strategies to help recover from pulmonary embolism

Recovery After Acute Pulmonary Embolism

This study tests if two healthy living strategies can help people recover better after being hospitalized for a pulmonary embolism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Rochester (Academic / other)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT06784492 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of two different healthy living strategies in aiding recovery for patients who have been hospitalized due to acute pulmonary embolism. Participants will undergo an 8-week program that includes these interventions alongside standard anticoagulation treatment. The primary outcome will be measured by assessing changes in cardiac effort during a six-minute walk test. The study seeks to determine if these lifestyle changes can enhance recovery outcomes for affected individuals.

Who should consider this trial

Good fit: Ideal candidates include English-speaking adults over 18 who have been hospitalized for acute pulmonary embolism and meet specific cardiac criteria.

Not a fit: Patients who are pregnant, have severe cardiac issues, or are unable to walk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve recovery rates and overall health outcomes for patients recovering from acute pulmonary embolism.

How similar studies have performed: While similar approaches have been explored, this specific combination of healthy living strategies in the context of acute pulmonary embolism recovery is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. English speaking (\>18 years old). Daily messages will be sent in English.
2. Acute PE with at least one of the following:

   1. any right ventricular enlargement or dysfunction on echocardiogram;
   2. CT Angiogram reporting any right ventricular enlargement; or
   3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
3. Rate controlled atrial arrythmias (resting heart rate \<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
4. Subjects do need to take prescribed anticoagulation.

Exclusion Criteria:

1. Pregnancy.
2. Cardiac Effort \>3.5 beats/m during 6MWT.
3. Resting tachycardia \>110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure \>180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (Recruiting)

Study contacts

• Study coordinator: Daniel J Lachant, DO

Conditions Acute Pulmonary Embolism; Recovery acute pulmonary embolism; Six minute walk; Cardiac Effort; actigraphy