80 Participants Needed

Home Rehabilitation for Pulmonary Embolism

DL
AR
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Overseen ByDaniel Lachant, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Home Rehabilitation for Pulmonary Embolism is an effective treatment?

The available research shows that home rehabilitation for pulmonary embolism can improve patients' quality of life and physical health. One study found that both supervised and unsupervised home rehabilitation programs led to better general and physical health scores, as well as improved sleep quality. Another study reported significant improvements in exercise capacity, with patients walking longer distances after completing a rehabilitation program. Additionally, most patients experienced long-term health benefits. These findings suggest that home rehabilitation is a beneficial treatment for those recovering from pulmonary embolism.12345

What data supports the effectiveness of the Home Rehabilitation Program for Pulmonary Embolism?

Research shows that an 8-week home-based exercise program can improve physical capacity and quality of life for patients with pulmonary embolism. Additionally, both supervised and unsupervised pulmonary rehabilitation programs have been found to enhance general health and sleep quality, suggesting that home rehabilitation could be a beneficial treatment option.12345

What safety data exists for home rehabilitation for pulmonary embolism?

The safety data for home rehabilitation programs, which may include self-monitored exercise and remote monitoring, suggest that these programs are generally safe for cardiac patients. Studies have shown that home-based exercise programs with monitoring, such as transtelephonic electrocardiographic monitoring and wearable sensors, are feasible and do not typically result in medical emergencies. These programs allow for the detection of specific issues that can be addressed, ensuring patient safety. The use of remote monitoring systems in cardiac rehabilitation has been piloted successfully, indicating that similar approaches could be safe for pulmonary embolism rehabilitation.678910

Is home rehabilitation for pulmonary embolism safe for humans?

Research on similar home-based rehabilitation programs for heart conditions shows they are generally safe, with no medical emergencies reported, although some issues required further evaluation. These programs often use monitoring systems to ensure safety during exercise.678910

Is the Home Rehabilitation Program a promising treatment for pulmonary embolism?

Yes, the Home Rehabilitation Program is a promising treatment for pulmonary embolism. It can improve physical capacity, quality of life, and sleep quality. Patients who participated in home-based rehabilitation showed improvements in their general and physical health, and many reported long-term health benefits.1251112

How does the Home Rehabilitation Program for Pulmonary Embolism differ from other treatments?

The Home Rehabilitation Program for Pulmonary Embolism is unique because it involves self-monitored daily physical activity tasks and heart rate monitoring, allowing patients to rehabilitate at home. This approach is novel as there are currently no standard rehabilitation options for pulmonary embolism, and it aims to improve physical capacity and quality of life without the need for supervised sessions.1251112

Research Team

Daniel J. Lachant, D.O. | UR Medicine

Daniel Lachant

Principal Investigator

University of Rochester

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and speak English.
I have a blood clot in my lungs with heart strain.
Baseline testing started within 7 days of hospital discharge.

Exclusion Criteria

Lack of access to email or text messaging.
My condition involves advanced neurological issues.
Inability to follow daily instructions.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily physical activity tasks sent through email or text, incorporating heart rate monitoring

12 weeks
Remote monitoring via email or text

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Control Text
  • Daily Activity Text
Trial OverviewThe 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.
Participant Groups
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".

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

American College of Chest Physicians

Collaborator

Trials
10
Recruited
2,200+

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.
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.
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]
In a study of 130 patients with pulmonary embolism (PE), 46% were treated entirely as outpatients, and 54% were discharged early, with a successful completion rate of 89% for the treatment program.
The treatment was generally safe, with only 2% experiencing major bleeding and 3% dying within 3 months, indicating that selected patients with sub-massive PE can be effectively managed at home, though careful monitoring is essential.
Management of pulmonary embolism in the home.Ong, BS., Karr, MA., Chan, DK., et al.[2020]

References

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]
Supervised Versus Unsupervised Pulmonary Rehabilitation in Patients with Pulmonary Embolism: A Valuable Alternative in COVID Era. [2021]
Management of pulmonary embolism in the home. [2020]
Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. [2022]
Outpatient Pulmonary Rehabilitation in Patients with Persisting Symptoms after Pulmonary Embolism. [2020]
Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. [2008]
Transtelephonic electrocardiographic monitoring of cardiac rehabilitation exercise sessions in coronary artery disease. [2019]
Implementing Wearable Sensors for Continuous Assessment of Daytime Heart Rate Response in Inpatient Rehabilitation. [2020]
Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. [2016]
Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]
A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. [2018]
Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. [2021]