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CompletedNCT05571189Updated Sep 18, 2026

Home Rehabilitation After Acute Pulmonary Embolism

An interventional study of Daily Activity Text and Control Text in Pulmonary Embolism, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Embolism

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03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 32 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralDaily Activity Text

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

  • BehavioralControl Text

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 weeks

  2. 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.

    Time frame: 10 weeks

Secondary outcomes

  1. proportion of participants with post-PE syndrome

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

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  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

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

    Time frame: 12 weeks

  10. 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.

    Time frame: 12 weeks

  11. proportion or subjects who develop chronic thromboembolic pulmonary hypertension

    Time frame: 12 weeks

07

Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
08

References and documents

Publications

  • Roto D, Haight D, Norton K, White RJ, Lachant D. Functional recovery after pulmonary embolism: A pilot study using metabolic monitoring during the 6-minute walk test. Respir Med. 2026 Mar;253:108707. doi: 10.1016/j.rmed.2026.108707. Epub 2026 Feb 7. PubMed 41662928 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05571189
Lead sponsor
University of Rochester
Collaborators
American College of Chest Physicians
Responsible party
Daniel Lachant (Assistant Professor, University of Rochester) — Principal investigator
First posted
Oct 7, 2022
Start date
Dec 19, 2022
Primary completion
Sep 24, 2025
Completion
Sep 24, 2025
Last update
Sep 18, 2026

Study contacts

Daniel Lachant, DO
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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