Home Rehabilitation After Acute Pulmonary Embolism

NCT05571189 | Completed

• 1 other identifier: STUDY00007680
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• proportion of participants with post-PE syndrome

  12 weeks

• mean change in steps as measured by Actigraph

  12 weeks

• mean change in activity as measured by Actigraph

  12 weeks

• mean change in quality of life as measured by PROMIS

  12 weeks

• mean change in quality of life as measured by Emphasis 10

  12 weeks

Study Arms (2)

Participants who receive daily activity message

EXPERIMENTAL

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

Behavioral: Daily Activity Text

Participants who receive control message

PLACEBO COMPARATOR

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

Interventions

Daily Activity Text BEHAVIORAL

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

Participants who receive daily activity message

Control Text BEHAVIORAL

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

Participants who receive control message

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• American College of Chest Physicians: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Lachant, DO

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: December 19, 2022
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)