Healthy Living Strategies for Pulmonary Embolism
(ERASE-PE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester
Must be taking: Anticoagulants
Disqualifiers: Pregnancy, Tachycardia, Hypertension, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must continue taking prescribed anticoagulation (blood thinners).
What data supports the effectiveness of the Healthy Living Intervention-1 and Healthy Living Intervention-2 treatments for pulmonary embolism?
The research suggests that exercise programs can improve physical capacity and quality of life for patients after a pulmonary embolism, which may support the effectiveness of Healthy Living Interventions that include exercise components.
12345Is the Healthy Living Strategies for Pulmonary Embolism treatment safe for humans?
The research on healthy lifestyle interventions, like maintaining a healthy weight, regular physical activity, and a balanced diet, generally shows they are safe for humans and can help prevent cardiovascular issues.
678910How is the Healthy Living Intervention treatment for pulmonary embolism different from other treatments?
The Healthy Living Intervention treatment for pulmonary embolism is unique because it focuses on lifestyle changes rather than medication or surgical procedures, which are the standard treatments. This approach may include exercise and health education, aiming to improve quality of life and physical capacity, especially since there are no documented rehabilitation options for PE patients.
25111213Eligibility Criteria
This trial is for English-speaking adults over 18 who've been hospitalized for pulmonary embolism. They must have signs of heart strain, like right ventricular enlargement on a CT scan or high levels of certain heart markers. Participants need to be on anticoagulants and can have controlled atrial arrhythmias with a resting heart rate under 110 beats per minute.Inclusion Criteria
I have a blood clot in my lung with heart strain or high heart markers.
I am over 18 and speak English.
I am required to take blood-thinning medication.
+1 more
Exclusion Criteria
Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities (e.g., cancer)
Systolic blood pressure >180 mmHg at hospital discharge
My heart rate increases by more than 3.5 beats per minute when I walk.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive daily messages about a healthy intervention along with anticoagulation for 8 weeks
8 weeks
Follow-up
Participants are monitored for changes in cardiac effort, health care utilization, and quality of life
3 months
Participant Groups
The ERAsE-PE study tests two healthy living strategies combined with standard anticoagulation therapy to see if they help recovery after pulmonary embolism. The effectiveness will be measured by changes in cardiac effort during a six-minute walk test after an eight-week program.
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Living Intervention-1Experimental Treatment1 Intervention
Participants who receive daily messages about a healthy intervention.
Group II: Healthy Living Intervention-2Active Control1 Intervention
Participants who receive daily messages about a different healthy intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Rochester Medical CenterRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. [2022]We aimed to determine the frequency and predictors of exercise limitation after pulmonary embolism (PE) and to assess its association with health-related quality of life (HRQoL) and dyspnea.
Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial. [2018]The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE.
Quality of life 1 month after acute pulmonary embolism in emergency department patients. [2023]The Pulmonary Embolism Quality-of-Life (PEmb-QoL) questionnaire assesses quality of life (QoL) after pulmonary embolism (PE). We aimed to determine whether any clinical or pathophysiologic features of PE were associated with worse PEmb-QoL scores 1 month after PE.
Assessing quality of life after pulmonary embolism: Comparing results from the PEmb-QoL with semistructured interviews. [2023]The Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) assesses quality of life (QoL) in patients with previous pulmonary embolism (PE).
Quality of life after pulmonary embolism: Prospective validation of the German version of the PEmb-QoL questionnaire. [2019]The Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) is a 40-item questionnaire to measure health-related quality of life in patients with pulmonary embolism. It covers six 6 dimensions: frequency of complaints, limitations in activities of daily living, work-related problems, social limitations, intensity of complaints, and emotional complaints. Originally developed in Dutch and English, we prospectively validated a German version of the PEmb-QoL.
Prepregnancy Healthy Lifestyle and Adverse Pregnancy Outcomes. [2023]To investigate the association of healthy lifestyle factors before pregnancy (body mass index [BMI] 18.5-24.9, nonsmoking, 150 min/wk or more of moderate-to-vigorous physical activity, healthy eating [top 40% of Dietary Approaches to Stop Hypertension score], no or low-to-moderate alcohol intake [less than 15 g/d], and use of multivitamins) with risk of adverse pregnancy outcomes.
Primary prevention of cardiovascular disease: an umbrella review. [2019]The aim of this study is to determine the effectiveness of non-pharmacological interventions for prevention of cardiovascular disease (CVD) events and mortality in healthy adults or those at high risk of CVD.
The Dynamic Interplay of Healthy Lifestyle Behaviors for Cardiovascular Health. [2023]The recent rise in cardiovascular disease (CVD) deaths in the USA has sparked interest in identifying and implementing effective strategies to reverse this trend. Healthy lifestyle behaviors (i.e., healthy diet, regular physical activity, achieve and maintain a healthy weight, avoid tobacco exposure, good quality sleep, avoiding and managing stress) are the cornerstone for CVD prevention.
An early, customized low-glycemic-index diet prevents adverse pregnancy outcomes in overweight/obese women. [2018]To determine whether the prescription and follow-up of a behavioral program (customized nutritional advices and a constant physical activity) influences the occurrence of unfavorable maternal/neonatal outcomes among overweight/obese women.
[Analysis of lifestyle and risk factors of atherosclerosis in students of selected universities in Krakow]. [2018]Reduction of risk factors of atherosclerosis, lifestyle modification significantly cause the reduction in the incidence, morbidity and mortality of cardiovascular diseases (CVDs). Objective: To evaluate cardiovascular risk factors and analyze the lifestyle of students finishing the first year of studies at selected universities in Krakow.
Genome- and transcriptome-wide association studies show that pulmonary embolism is associated with bone-forming proteins. [2022]Pulmonary embolism (PE) is a leading cause of death in stroke patients and a severe health burden worldwide. There is a pressing need to understand the mechanisms by which it occurs and to identify at-risk patients efficiently and accurately.
Health literacy in patients with pulmonary embolism: development and validation of the HeLP (Health Literacy in Pulmonary Embolism)-Questionnaire. [2023]Pulmonary embolism (PE) is a common cardiovascular disease and health literacy is necessary to deal with its consequences after the acute event. The aim of this study was to develop and validate a new questionnaire to measure PE-specific health literacy.
Interventions in pulmonary embolism. [2019]Various interventions are available to assist in the management of patients with pulmonary embolism. Most are reserved for patients who either fail standard systemic anticoagulation therapy or are not candidates for anticoagulant therapy. The most common intervention is placement of a vena caval filter. Several different filter devices are available, most of which may be placed percutaneously. Pulmonary thrombolysis with urokinase or streptokinase may be appropriate in some patients with severe, symptomatic pulmonary embolism. Finally, pulmonary embolectomy by means of either a transvenous catheter or surgical technique may be necessary in cases of refractory cardiovascular collapse.