Home Rehabilitation After Acute Pulmonary Embolism

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Behavioral: Daily Activity Text; Behavioral: Control Text

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants who receive daily activity message; The intervention group will receive instructions for a daily activity sent through SMS text message or email.	Behavioral: Daily Activity Text; Participants will receive a text each day with instructions about the daily activity they should complete for that day.
Placebo Comparator: 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".	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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in vector magnitude count as measured by actigraphy	The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the vector magnitude count.	10 weeks
mean change in mean amplitude deviation as measured by actigraphy	The Actigraph triaxial accelerometer will be used to monitor continuous activity at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the mean amplitude deviation.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of participants with post-PE syndrome	Participants will be evaluated by a physician to determine if they have post PE-syndrome	12 weeks
mean change in steps as measured by Actigraph	The Actigraph triaxial accelerometer will be used to monitor the number of steps taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the step count.	12 weeks
mean change in activity as measured by Actigraph	The Actigraph triaxial accelerometer will be used to monitor the amount of activity taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the amount of activity.	12 weeks
mean change in quality of life as measured by PROMIS	The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome.	12 weeks
mean change in quality of life as measured by Emphasis 10	The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life.	12 weeks
mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire	The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes.	12 weeks
mean change in 6 minute walking distance		12 weeks
mean change in heart rate during a 6 minute walk		12 weeks
mean change in oxygen use during a 6 minute walk	Oxygen use will be measured by a measured by portable K5 metabolic analyzer.	12 weeks
mean change in carbon dioxide production during a 6 minute walk	Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer.	12 weeks
proportion or subjects who develop chronic thromboembolic pulmonary hypertension		12 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: American College of Chest Physicians
• Investigators: Principal Investigator: Daniel Lachant, DO, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: STUDY00007680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No