Clinical trial NCT05571189: Home Rehabilitation After Acute Pulmonary Embolism
Official title: Home Rehabilitation After Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: American College of Chest Physicians
First posted: 2022-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: mean change in vector magnitude count as measured by actigraphy
timeFrame: 10 weeks
measure: mean change in mean amplitude deviation as measured by actigraphy
timeFrame: 10 weeks
Secondary outcomes:
measure: proportion of participants with post-PE syndrome
timeFrame: 12 weeks
measure: mean change in steps as measured by Actigraph
timeFrame: 12 weeks
measure: mean change in activity as measured by Actigraph
timeFrame: 12 weeks
measure: mean change in quality of life as measured by PROMIS
timeFrame: 12 weeks
measure: mean change in quality of life as measured by Emphasis 10
timeFrame: 12 weeks
measure: mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire
timeFrame: 12 weeks
measure: mean change in 6 minute walking distance
timeFrame: 12 weeks
measure: mean change in heart rate during a 6 minute walk
timeFrame: 12 weeks
measure: mean change in oxygen use during a 6 minute walk
timeFrame: 12 weeks
measure: mean change in carbon dioxide production during a 6 minute walk
timeFrame: 12 weeks
measure: proportion or subjects who develop chronic thromboembolic pulmonary hypertension
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Daniel Lachant, DO
role: PRINCIPAL_INVESTIGATOR
References: