Exercise Training for Pulmonary Embolism

Overseen By Stan Henkin, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to ambulate, Prior PE, CTEPH, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home exercise program for individuals with certain types of pulmonary embolism (blood clots in the lungs). The researchers aim to determine if home exercise can improve recovery compared to standard care. Participants will either follow the new exercise program or continue with the usual treatment without additional exercises. Suitable candidates include those with recent pulmonary embolism symptoms, such as sudden chest pain or difficulty breathing, and a diagnosis of blood clots in lung vessels. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise training is safe for pulmonary embolism patients?

Research has shown that exercise is generally safe for individuals who have experienced a pulmonary embolism (PE), a blockage in the lungs. One study found that a 3-month exercise program following a PE did not result in deaths, major bleeding, or frequent hospital visits. Additionally, a review of several studies suggests that exercise is both safe and feasible for PE patients. While these findings are encouraging, the long-term effects remain unclear. Overall, exercise appears to be a safe option for those recovering from PE. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pulmonary embolism, such as anticoagulants and thrombolytics, focus on breaking up or preventing blood clots. However, the home-based exercise training being explored offers a unique approach. This method aims to improve the patient's overall cardiovascular fitness and respiratory function from the comfort of their home. Researchers are excited about this because it could enhance recovery and quality of life without the need for hospital visits, potentially making it a more accessible and less invasive option for patients.

What evidence suggests that home-based exercise is effective for pulmonary embolism?

This trial will compare home-based exercise training with standard therapy for individuals recovering from pulmonary embolism (PE). Studies have shown that exercise can improve fitness and quality of life for those who have experienced a PE. Many PE survivors often face challenges such as difficulty breathing and limited ability to exercise. Research indicates that home-based exercise can lead to better health, with 78% of patients noticing positive changes. While more evidence is still being gathered, these exercise programs appear to enhance physical fitness and overall well-being for those recovering from PE. ^{1 3 4 5 6}

Who Is on the Research Team?

Stan Henkin, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who have had a pulmonary embolism, which is a blockage in the lungs. Participants must have low blood pressure or shock due to the embolism, signs of heart strain on imaging tests, and confirmed blockages in lung vessels. People with chronic conditions causing these symptoms cannot join.

Inclusion Criteria

My scans show a blockage in the blood vessels of my lungs.

I have low blood pressure or shock due to a lung blood clot.

My heart's right ventricle is enlarged due to a recent pulmonary embolism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in home-based exercise training using an Interactive Care Plan

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for changes in physical capacity and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Exercise

Trial Overview The study is testing a home-based exercise program designed by heart specialists and physiologists. It aims to improve mobility outcomes for patients after experiencing a pulmonary embolism using an Interactive Care Plan.

How Is the Trial Designed?

Group I: Home-Based Exercise Training Experimental Treatment 1 Intervention

Group II: Standard therapy (Standard of Care) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a randomized controlled trial involving 24 patients with acute pulmonary embolism, high-intensity interval training (HIIT) significantly improved exercise capacity (eV˙O2max increased by 65%), lung function (FEV1 improved by 17%), and right ventricular function (RV/LV ratio decreased by 27%) over 8 weeks.

The HIIT program was safe, with all participants tolerating the exercise without serious adverse events, while the control group showed no improvements and even a slight decline in lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial. Ghram, A., Jenab, Y., Soori, R., et al.[2023]

Outpatient pulmonary rehabilitation (PR) for patients with pulmonary embolism (PE) led to significant improvements in exercise capacity, as measured by the 6-minute walk test, with an average increase of 49.4 meters after a 6-week program involving 22 patients.

At a median follow-up of 39 months, 78% of patients reported long-term improvements in their health status, indicating that PR can have lasting benefits for PE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Pulmonary Rehabilitation in Patients with Persisting Symptoms after Pulmonary Embolism. Nopp, S., Klok, FA., Moik, F., et al.[2020]

Pulmonary rehabilitation (PR) over 8 weeks is safe and beneficial for patients with pulmonary embolism (PE), showing improvements in quality of life and sleep quality for both supervised (SPR) and unsupervised (unSPR) groups.

Both groups experienced significant enhancements in general and physical health scores, as well as reductions in sleep disturbances, indicating that PR can effectively support recovery in PE patients regardless of supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Versus Unsupervised Pulmonary Rehabilitation in Patients with Pulmonary Embolism: A Valuable Alternative in COVID Era. Stavrou, VT., Griziotis, M., Vavougios, GD., et al.[2021]

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]

Exercise-based rehabilitation is safe for patients with venous thromboembolism (VTE), including those with deep vein thrombosis (DVT), pulmonary embolism (PE), and postthrombotic syndrome (PTS), based on a review of nine studies.

However, there is limited evidence to suggest that regular exercise significantly improves exercise capacity in VTE patients, indicating a need for more robust studies in this emerging field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise training in treating venous thromboembolism: a systematic review. Xu, L., Fu, C., Zhang, Q., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12284715/

Exercise and pulmonary embolism: a systematic review of ... Long-term survivors of pulmonary embolism (PE) exhibit decreased exercise capacity, dyspnoea and a diminished quality of life.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2475037925000603

Exercise capacity, dyspnea, and quality of life 6 months ... Many pulmonary embolism (PE) survivors report persistent dyspnea, reduced exercise capacity, functional limitations, and an impaired health-related quality of ...

3. jtd.amegroups.org jtd.amegroups.org/article/view/93547/html

Effect of exercise on physical fitness and quality of life in ... This meta-analysis suggested that exercise programs may have some effect on patients with pulmonary embolism (PE), but the evidence remains inconclusive.

4. researchgate.net researchgate.net/publication/394452006_Home_Based_Exercise_Training_To_Improve_Aerobic_Capacity_And_Functional_Limitations_Of_A_Patient_Following_Pulmonary_Embolism_A_Case_Report

(PDF) Home Based Exercise Training To Improve Aerobic ... At long-term follow-up, 78% of patients reported improved health. Conclusion: We observed significant improvements in exercise capacity in PE ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8209689/

Safety of exercise therapy after acute pulmonary embolism We implemented a 3-month exercise program after acute PE. Outcomes were death, bleeding, readmissions, recurrent events, changes in peak VO2 and quality of life ...

6. publications.ersnet.org publications.ersnet.org/content/errev/34/177/240241

Exercise and pulmonary embolism: a systematic review of ... This systematic review indicates that exercise training seems to be safe and feasible for patients with PE. It appears to enhance patients' exercise capacity ...