Home Rehabilitation After Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Home Rehabilitation After Acute Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571189
• Other study ID #: STUDY00007680
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: University of Rochester
• Contact: Daniel Lachant, DO
• Phone: 5852769357
• Email: daniel_lachant[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Behavioral:
• Daily Activity Text
Participants will receive a text each day with instructions about the daily activity they should complete for that day.
• Control Text
Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	American College of Chest Physicians

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	proportion of participants with post-PE syndrome	Participants will be evaluated by a physician to determine if they have post PE-syndrome	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	mean change in 6 minute walking distance		12 weeks
Secondary	mean change in heart rate during a 6 minute walk		12 weeks
Secondary	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
Secondary	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
Secondary	proportion or subjects who develop chronic thromboembolic pulmonary hypertension		12 weeks