Healthy Living Strategies for Pulmonary Embolism

(ERASE-PE Trial)

Overseen By Daniel J Lachant, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Anticoagulants

Disqualifiers: Pregnancy, Tachycardia, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{2 5 11 12 13}

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.

Eligibility 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 required to take blood-thinning medication.

My heart rate is under 110 beats per minute, even with atrial fibrillation.

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.

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

Treatment Details

Interventions

• Healthy Living Intervention-1
• Healthy Living Intervention-2

Trial Overview 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.

Participant Groups

Group I: Healthy Living Intervention-1 Experimental Treatment 1 Intervention

Participants who receive daily messages about a healthy intervention.

Group II: Healthy Living Intervention-2 Active Control 1 Intervention

Participants who receive daily messages about a different healthy intervention.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Nearly 46.5% of patients with acute pulmonary embolism (PE) experienced exercise limitations one year after their diagnosis, which negatively impacted their health-related quality of life (HRQoL) and walking distance.

Key predictors of exercise limitation included male sex, age, body mass index (BMI), smoking history, and initial exercise capacity measured by peak oxygen uptake (Vo2 peak) and 6-minute walk distance (6MWD) at one month post-PE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Kahn, SR., Hirsch, AM., Akaberi, A., et al.[2022]

An 8-week home-based exercise program is being tested on 140 patients with first-time pulmonary embolism (PE) to see if it can improve their physical capacity and quality of life after hospital discharge.

The study aims to fill a gap in rehabilitation options for PE patients, as current evidence mainly focuses on diagnosis and treatment, and it may lead to future recommendations for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rolving, N., Brocki, BC., Mikkelsen, HR., et al.[2018]

In a study of 788 patients who experienced pulmonary embolism (PE), factors such as rehospitalization, chronic obstructive pulmonary disease (COPD), and longer hospital stays were found to significantly predict worse quality of life (QoL) scores one month after the event.

Interestingly, acute clinical deterioration and right ventricular dysfunction (RVD) did not correlate with poorer QoL outcomes, suggesting that other factors may play a more critical role in long-term recovery and well-being after PE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life 1 month after acute pulmonary embolism in emergency department patients. Weekes, AJ., Davison, J., Lupez, K., et al.[2023]

A study involving 21 patients revealed that qualitative interviews about their quality of life (QoL) after pulmonary embolism (PE) indicated more functional impairment than what was measured by the Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL).

There was a significant disagreement between the PEmb-QoL scores and patients' reported experiences, particularly regarding fear of recurrence and the ability to engage in hobbies, suggesting that qualitative methods should be integrated with quantitative assessments for a more comprehensive understanding of QoL in PE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing quality of life after pulmonary embolism: Comparing results from the PEmb-QoL with semistructured interviews. Hernandez-Nino, J., Ott, MA., Thomas, M., et al.[2023]

The German version of the Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) has been validated as a reliable tool for measuring health-related quality of life in patients with pulmonary embolism, based on a study of 102 patients.

The questionnaire demonstrated good internal consistency and test-retest reliability, and identified four key dimensions affecting quality of life: limitations in daily activities, symptoms, work-related problems, and emotional complaints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life after pulmonary embolism: Prospective validation of the German version of the PEmb-QoL questionnaire. Frey, PM., Méan, M., Limacher, A., et al.[2019]

A study involving 15,509 women and 27,135 pregnancies found that adopting six healthy lifestyle factors before pregnancy significantly reduces the risk of adverse pregnancy outcomes by 37%.

Key factors such as maintaining a healthy BMI, following a high-quality diet, and taking multivitamins were particularly effective in lowering risks of complications like gestational diabetes and low birth weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prepregnancy Healthy Lifestyle and Adverse Pregnancy Outcomes. Wang, S., Mitsunami, M., Ortiz-Panozo, E., et al.[2023]

Four non-pharmacological interventions—vitamin D supplements, increased omega-3 fatty acid intake, Qigong, and counseling for cardiovascular risk factor modification—significantly reduce the risk of cardiovascular disease (CVD) events and mortality in healthy adults or those at high risk.

The study included 24 reviews, with 13 reporting relevant outcomes, and found that while some adverse events were noted, they were generally minor and not significantly different from the control group, indicating a favorable safety profile for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention of cardiovascular disease: an umbrella review. Martin Ruiz, E., Olry de Labry, A., Epstein, D.[2019]

Adopting healthy lifestyle behaviors, such as a balanced diet, regular exercise, and good sleep, is crucial for preventing cardiovascular disease (CVD) and can significantly reduce CVD risk, even with small changes.

There is a strong connection between different lifestyle behaviors; improving one can lead to improvements in others, while unhealthy behaviors can hinder positive changes, highlighting the need for comprehensive assessments in patient interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dynamic Interplay of Healthy Lifestyle Behaviors for Cardiovascular Health. Kris-Etherton, PM., Sapp, PA., Riley, TM., et al.[2023]

A behavioral program that included a low-glycemic-index diet and regular physical activity significantly reduced the occurrence of gestational diabetes mellitus (GDM) in overweight/obese pregnant women, with GDM rates at 21.5% in the intervention group compared to 32.7% in the control group.

The intervention also led to a lower incidence of pregnancy-induced hypertension (PIH) and preterm birth, with only 1.1% of cases experiencing PIH compared to 11.6% in controls, and only 1 case of preterm birth in the intervention group versus 28 in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An early, customized low-glycemic-index diet prevents adverse pregnancy outcomes in overweight/obese women. Petrella, E., Tamborrino, V., Di Cerbo, L., et al.[2018]

A study of 566 first-year university students in Krakow revealed that students from the AGH and Academy of Fine Arts (ASP) exhibited the highest cardiovascular risk factors, including higher alcohol consumption and lower rates of healthy eating habits.

Only 34.8% of students regularly consumed fish, and while 60% had never tried drugs, the Fine Arts students had the highest rate of drug experimentation, highlighting the need for targeted health interventions at these universities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of lifestyle and risk factors of atherosclerosis in students of selected universities in Krakow]. Skrzypek, A., Szeliga, M., Stalmach-Przygoda, A., et al.[2018]

The study identified five plasma proteins linked to pulmonary embolism (PE), including hydroxycarboxylic acid receptor 2 and bone morphogenetic protein (BMP) 7, suggesting potential biomarkers for identifying at-risk patients.

There is a significant genetic correlation between PE and the BMP family of genes, indicating that these proteins may play a crucial role in the mechanisms underlying PE, which could help in developing targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome- and transcriptome-wide association studies show that pulmonary embolism is associated with bone-forming proteins. Feng, R., Lu, M., Yang, Y., et al.[2022]

The HeLP Questionnaire, developed to measure health literacy specific to pulmonary embolism (PE), consists of 23 items across four domains and demonstrated strong reliability (Cronbach's alpha: 0.82 to 0.90) in a study involving 238 patients with PE.

Qualitative and quantitative analyses confirmed the questionnaire's structural validity, indicating it effectively captures key aspects of PE-related health literacy, such as disease management and health-related self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy in patients with pulmonary embolism: development and validation of the HeLP (Health Literacy in Pulmonary Embolism)-Questionnaire. Fischer, S., Kalch, A., Küchler, C., et al.[2023]

Vena caval filters are the most common intervention for managing pulmonary embolism, particularly for patients who cannot use standard anticoagulation therapy or have not responded to it.

In severe cases of pulmonary embolism, treatments like pulmonary thrombolysis with urokinase or streptokinase, and pulmonary embolectomy may be necessary to restore blood flow and stabilize the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions in pulmonary embolism. McCowan, TC., Eidt, JF., Ferris, EJ.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Quality of life 1 month after acute pulmonary embolism in emergency department patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Assessing quality of life after pulmonary embolism: Comparing results from the PEmb-QoL with semistructured interviews. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of life after pulmonary embolism: Prospective validation of the German version of the PEmb-QoL questionnaire. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Prepregnancy Healthy Lifestyle and Adverse Pregnancy Outcomes. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

Primary prevention of cardiovascular disease: an umbrella review. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The Dynamic Interplay of Healthy Lifestyle Behaviors for Cardiovascular Health. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

An early, customized low-glycemic-index diet prevents adverse pregnancy outcomes in overweight/obese women. [2018]

10. Poland pubmed.ncbi.nlm.nih.gov

[Analysis of lifestyle and risk factors of atherosclerosis in students of selected universities in Krakow]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Genome- and transcriptome-wide association studies show that pulmonary embolism is associated with bone-forming proteins. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Health literacy in patients with pulmonary embolism: development and validation of the HeLP (Health Literacy in Pulmonary Embolism)-Questionnaire. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Interventions in pulmonary embolism. [2019]