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Completed

NCT Number: NCT05571189

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily Activity Text

Behavioral

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

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."

Primary outcomes

  1. mean change in vector magnitude count as measured by actigraphy

    Time frame: 10 weeks

    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.

  2. mean change in mean amplitude deviation as measured by actigraphy

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. proportion of participants with post-PE syndrome

    Time frame: 12 weeks

    Participants will be evaluated by a physician to determine if they have post PE-syndrome

  2. mean change in steps as measured by Actigraph

    Time frame: 12 weeks

    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.

  3. mean change in activity as measured by Actigraph

    Time frame: 12 weeks

    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.

  4. mean change in quality of life as measured by PROMIS

    Time frame: 12 weeks

    The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome.

  5. mean change in quality of life as measured by Emphasis 10

    Time frame: 12 weeks

    The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life.

  6. mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire

    Time frame: 12 weeks

    The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes.

  7. mean change in 6 minute walking distance

    Time frame: 12 weeks

  8. mean change in heart rate during a 6 minute walk

    Time frame: 12 weeks

  9. mean change in oxygen use during a 6 minute walk

    Time frame: 12 weeks

    Oxygen use will be measured by a measured by portable K5 metabolic analyzer.

  10. mean change in carbon dioxide production during a 6 minute walk

    Time frame: 12 weeks

    Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer.

  11. proportion or subjects who develop chronic thromboembolic pulmonary hypertension

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • American College of Chest Physicians

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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