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Home Rehabilitation for Pulmonary Embolism

N/A

Recruiting

Led By Daniel Lachant, DO

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin).

Be older than 18 years old

Must not have

Advanced neurologic disease.

Suspicion for Chronic Thromboembolic Pulmonary Hypertension.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will help improve understanding of how to better manage acute pulmonary embolism.

Who is the study for?

This trial is for English-speaking adults over 18 who've been hospitalized with acute pulmonary embolism and show certain heart issues. They must be able to start the program within a week of leaving the hospital, walk on their own, and have access to email or text messaging.

What is being tested?

The study tests if a home rehab program using daily physical activity tasks sent via email or text can improve outcomes after an acute pulmonary embolism compared to usual care. Heart rate is monitored during these activities.

What are the potential side effects?

Since this trial involves basic exercise guided by texts or emails, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, specific risks will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood clot in my lungs with heart strain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition involves advanced neurological issues.

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I might have high blood pressure in my lungs due to clots.

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I am unable to walk.

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My heart rate increases by more than 2.5 beats per minute during a 6-minute walk test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

mean change in mean amplitude deviation as measured by actigraphy

Actigraphy

Secondary study objectives

mean change in activity as measured by Actigraph

mean change in carbon dioxide production during a 6 minute walk

mean change in oxygen use during a 6 minute walk

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants who receive daily activity messageExperimental Treatment1 Intervention

The intervention group will receive instructions for a daily activity sent through SMS text message or email.

Group II: Participants who receive control messagePlacebo Group1 Intervention

The control group will receive daily messages to help with blinding sent through text message or email. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".

0 / 5Eligibility criteria met