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Home Rehabilitation for Pulmonary Embolism
N/A
Recruiting
Led By Daniel Lachant, DO
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will help improve understanding of how to better manage acute pulmonary embolism.
Who is the study for?
This trial is for English-speaking adults over 18 who've been hospitalized with acute pulmonary embolism and show certain heart issues. They must be able to start the program within a week of leaving the hospital, walk on their own, and have access to email or text messaging.Check my eligibility
What is being tested?
The study tests if a home rehab program using daily physical activity tasks sent via email or text can improve outcomes after an acute pulmonary embolism compared to usual care. Heart rate is monitored during these activities.See study design
What are the potential side effects?
Since this trial involves basic exercise guided by texts or emails, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, specific risks will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blood clot in my lungs with heart strain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean change in mean amplitude deviation as measured by actigraphy
Actigraphy
Secondary outcome measures
mean change in 6 minute walking distance
mean change in activity as measured by Actigraph
mean change in carbon dioxide production during a 6 minute walk
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants who receive daily activity messageExperimental Treatment1 Intervention
The intervention group will receive instructions for a daily activity sent through SMS text message or email.
Group II: Participants who receive control messagePlacebo Group1 Intervention
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".
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Who is running the clinical trial?
American College of Chest PhysiciansOTHER
5 Previous Clinical Trials
1,935 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
746 Patients Enrolled for Pulmonary Embolism
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,170 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
218 Patients Enrolled for Pulmonary Embolism
Daniel Lachant, DOPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and speak English.My condition involves advanced neurological issues.Your doctor thinks you may not live more than 12 months because of other health problems.I have a blood clot in my lungs with heart strain.I am unable to walk.I might have high blood pressure in my lungs due to clots.You have been regularly doing structured exercise at least three days per week for the last four weeks.Your heart rate is less than 1.2 beats per minute during the 6-minute walk test, so the treatment may not help you.My heart rate increases by more than 2.5 beats per minute during a 6-minute walk test.Your resting heart rate is higher than 120 beats per minute during screening or when leaving the hospital.Your blood pressure is higher than 180 mmHg at the time of screening or when leaving the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Participants who receive control message
- Group 2: Participants who receive daily activity message
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pulmonary Embolism Patient Testimony for trial: Trial Name: NCT05571189 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open positions available to participate in this experiment?
"Per the information available on clinicaltrials.gov, this experiment is open for recruitment. It was originally announced on November 7th 2022 and has had its details updated recently, as of November 8th 2022."
Answered by AI
How many participants are enrolled in this clinical trial?
"Affirmative, the information hosted on clinicaltrials.gov states that this medical investigation is presently seeking participants. Initially posted on November 7th 2022 and recently updated on November 8th 2022, it requires 80 individuals from 1 centre to take part in the study."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
University of Rochester Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Just to learn more about my condition and to learn to live with it everyday.
PatientReceived 2+ prior treatments
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