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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.

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 data supports the effectiveness of the home-based exercise treatment for pulmonary embolism?

Research suggests that home-based exercise programs can improve physical capacity and quality of life in patients with pulmonary embolism. Studies have shown that both supervised and unsupervised pulmonary rehabilitation can enhance general and physical health, as well as sleep quality, indicating that exercise is a safe and beneficial treatment for these patients. ^{1 2 3 4 5}

Is exercise training safe for people with pulmonary embolism?

Research suggests that exercise training, including home-based and supervised programs, is generally safe for people with pulmonary embolism and other related conditions. However, exercise plans should be tailored to individual health needs. ^{1 2 3 6 7}

How is home-based exercise training unique for treating pulmonary embolism?

Home-based exercise training for pulmonary embolism is unique because it offers a rehabilitation option that can be done at home, focusing on improving physical capacity and quality of life, which are not typically addressed by standard medical treatments for this condition. ^{1 2 3 5 8}

Research Team

Stan Henkin, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Supervised Versus Unsupervised Pulmonary Rehabilitation in Patients with Pulmonary Embolism: A Valuable Alternative in COVID Era. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise training in treating venous thromboembolism: a systematic review. [2021]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Outpatient Pulmonary Rehabilitation in Patients with Persisting Symptoms after Pulmonary Embolism. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Standardized exercise training is feasible, safe, and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension: results from a large European multicentre randomized controlled trial. [2022]

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

High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Quantitative evaluation of cardiopulmonary functional reserve in treated patients with pulmonary embolism. [2012]