Pulmonary EmbolismNCT05571189
Home Rehabilitation After Acute Pulmonary Embolism
A study testing Daily Activity Text in people with Pulmonary Embolism, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Daily Activity Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2022to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
- Being tested
- Daily Activity Text, Control Text
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Activity TextBehavioural
Participants will receive a text each day with instructions about the daily activity they should complete for that day.
Control TextBehavioural
Participants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day."
| Study group | Role | What they receive |
|---|---|---|
| Participants who receive daily activity message | Experimental | The intervention group will receive instructions for a daily activity sent through SMS text message or email. Receives: 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". Receives: Behavioral: Control Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (11)
proportion of participants with post-PE syndrome
Participants will be evaluated by a physician to determine if they have post PE-syndrome
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
mean change in 6 minute walking distance
Measured: 12 weeks
mean change in heart rate during a 6 minute walk
Measured: 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.
Measured: 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.
Measured: 12 weeks
proportion or subjects who develop chronic thromboembolic pulmonary hypertension
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start19 Dec 2022
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Chest Physicians
- Responsible party
- Principal investigator, Daniel Lachant, University of Rochester
- Investigators
- Daniel Lachant, DO, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571189
- Sponsor's protocol ID
- STUDY00007680
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Rehabilitation After Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05571189
- Acronym / sponsor ID
- STUDY00007680
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American College of Chest Physicians
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who receive daily activity message | Experimental | Behavioral: Daily Activity TextThe intervention group will receive instructions for a daily activity sent through SMS text message or email. |
| Participants who receive control message | Placebo comparator | Behavioral: Control TextThe 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Activity TextParticipants will receive a text each day with instructions about the daily activity they should complete for that day. | Behavioural | Participants who receive daily activity message |
| Control TextParticipants will receive a text each day with no instructions about daily activity. It will have messages like "have a nice day." | Behavioural | Participants who receive control message |
Primary outcome
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.
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.
11 secondary outcomes
proportion of participants with post-PE syndrome
Time frame: 12 weeks
mean change in steps as measured by Actigraph
Time frame: 12 weeks
mean change in activity as measured by Actigraph
Time frame: 12 weeks
mean change in quality of life as measured by PROMIS
Time frame: 12 weeks
mean change in quality of life as measured by Emphasis 10
Time frame: 12 weeks
mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire
Time frame: 12 weeks
mean change in 6 minute walking distance
Time frame: 12 weeks
mean change in heart rate during a 6 minute walk
Time frame: 12 weeks
mean change in oxygen use during a 6 minute walk
Time frame: 12 weeks
mean change in carbon dioxide production during a 6 minute walk
Time frame: 12 weeks
proportion or subjects who develop chronic thromboembolic pulmonary hypertension
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 41662928Roto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lachant, DO principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Activity Text in people with Pulmonary Embolism, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in vector magnitude count as measured by actigraphy (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.