Home Rehabilitation After Acute Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Interventions
- Behavioral: Daily Activity TextBehavioral: Control Text
- Registration Number
- NCT05571189
- Lead Sponsor
- University of Rochester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants who receive daily activity message Daily Activity Text The intervention group will receive instructions for a daily activity sent through SMS text message or email. Participants who receive control message Control Text 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".
- Primary Outcome Measures
Name Time Method mean change in vector magnitude count as measured by actigraphy 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 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 Outcome Measures
Name Time Method mean change in 6 minute walking distance 12 weeks mean change in oxygen use during a 6 minute walk 12 weeks Oxygen use will be measured by a measured by portable K5 metabolic analyzer.
mean change in quality of life as measured by Pulmonary Embolism quality of life questionnaire 12 weeks The pulmonary embolism quality of life questionnaire ranges from 1 to 27 with higher scores indicating worse outcomes.
mean change in carbon dioxide production during a 6 minute walk 12 weeks Carbon Dioxide use will be measured by a measured by portable K5 metabolic analyzer.
mean change in quality of life as measured by PROMIS 12 weeks The PROMIS questionnaire ranges from 0-99 with higher scores indicating worse outcome.
proportion of participants with post-PE syndrome 12 weeks Participants will be evaluated by a physician to determine if they have post PE-syndrome
mean change in steps as measured by Actigraph 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.
mean change in activity as measured by Actigraph 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.
mean change in quality of life as measured by Emphasis 10 12 weeks The Emphasis 10 questionnaire ranges from 0-50 with higher scores indicating worse quality of life.
mean change in heart rate during a 6 minute walk 12 weeks proportion or subjects who develop chronic thromboembolic pulmonary hypertension 12 weeks
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States