Home Rehabilitation After Acute Pulmonary Embolism

NCT ID: NCT05571189

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2025-09-24

Brief Summary

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The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Participants who receive daily activity message

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

Group Type EXPERIMENTAL

Daily Activity Text

Intervention Type BEHAVIORAL

Participants will receive a text each day with instructions about the daily activity they should complete for that day.

Participants who receive control message

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".

Group Type PLACEBO_COMPARATOR

Control Text

Intervention Type BEHAVIORAL

Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."

Interventions

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Daily Activity Text

Participants will receive a text each day with instructions about the daily activity they should complete for that day.

Intervention Type BEHAVIORAL

Control Text

Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English speaking (\>18 years old). Daily messages will be sent in English.
* Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin).
* Baseline testing started within 7 days of hospital discharge.

Exclusion Criteria

* Pregnancy.
* Cardiac Effort \>2.5 beats/m during 6MWT. This is for safety.
* Cardiac Effort \<1.2 beats/m during 6MWT. They are unlikely to benefit.
* Resting tachycardia \>120 beats/m during screening or at hospital discharge.
* Suspicion for Chronic Thromboembolic Pulmonary Hypertension.
* Systolic blood pressure \>180 mmHg during screening or at hospital discharge.
* Inability to walk.
* Estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities.
* Advanced neurologic disease.
* Lack of access to email or text messaging.
* Inability to follow daily instructions.
* Participation in a structured exercise routine at least three days per week in the prior four weeks.
* Principal Investigator discretion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Chest Physicians

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lachant

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Lachant, DO

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00007680

Identifier Type: -

Identifier Source: org_study_id

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