Home Rehabilitation for Pulmonary Embolism

Recruiting in Palo Alto (17 mi)

Overseen by Daniel Lachant

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 5 11 12}

Research Team

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.

Treatment Details

Interventions

• Control Text (Behavioral Intervention)
• Daily Activity Text (Behavioral Intervention)

Trial Overview The 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

Group I: Participants who receive daily activity message Experimental Treatment 1 Intervention

The intervention group will receive instructions for a daily activity sent through SMS text message or email.

Group II: Participants who receive control message Placebo Group 1 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".

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

American College of Chest Physicians

Collaborator

Trials

10

Recruited

2,200+

Findings from Research

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism in the home. Ong, BS., Karr, MA., Chan, DK., et al.[2020]

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]

A self-monitored, home-based exercise program for high-risk cardiac surgery patients was found to be safe, with no cardiovascular complications reported during the eight-week training period.

However, the exercise program did not significantly improve aerobic capacity compared to a control group that received general activity guidelines, indicating that the home-based approach may not provide additional benefits in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. Brosseau, R., Juneau, M., Sirard, A., et al.[2008]

Transtelephonic monitoring of exercise sessions for 67 cardiac patients was found to be safe and reliable, with only one system failure reported during 1,865 sessions, indicating its effectiveness for remote cardiac rehabilitation.

The program successfully identified 18 specific health issues in patients without any medical emergencies, demonstrating that remote monitoring can enhance patient safety and optimize the use of cardiac rehabilitation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transtelephonic electrocardiographic monitoring of cardiac rehabilitation exercise sessions in coronary artery disease. Squires, RW., Miller, TD., Harn, T., et al.[2019]

In a study involving patients aged 44-80 in inpatient rehabilitation, 60% of subjects achieved target heart rate (THR) levels necessary for cardiorespiratory benefits, indicating that wearable heart rate sensors are effective for monitoring training responses.

The study found that 47% of subjects experienced episodes of excessive heart rate (EHR), but importantly, there were no adverse events related to the sensors, demonstrating their safety and feasibility for continuous monitoring in a rehabilitation setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Wearable Sensors for Continuous Assessment of Daytime Heart Rate Response in Inpatient Rehabilitation. Weeks, DL., Sprint, GL., Stilwill, V., et al.[2020]

In a randomized controlled trial involving 126 hospitalized cardiac patients, those who engaged in self-monitoring of their physical activity significantly increased their daily steps and energy expenditure before transitioning to phase II cardiac rehabilitation, compared to those who did not self-monitor.

The self-monitoring group averaged 8609.6 steps and 242.6 kcal of energy expenditure, while the control group averaged only 5512.9 steps and 155.9 kcal, indicating that self-monitoring can effectively enhance physical activity levels in cardiac patients during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. Izawa, KP., Watanabe, S., Hiraki, K., et al.[2016]

This trial will compare the effectiveness of self-monitored, home-based rehabilitation versus traditional hospital-based rehabilitation in 240 patients with moderate to severe COPD, aiming to determine if home-based methods can be as effective in improving patients' breathing difficulties over 12 months.

The study will also evaluate whether home-based rehabilitation can lead to reduced healthcare usage and lower costs compared to hospital-based rehabilitation, addressing important gaps in pulmonary rehabilitation accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. Maltais, F., Bourbeau, J., Lacasse, Y., et al.[2018]

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. Australia pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism in the home. [2020]

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

Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. [2008]

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

Transtelephonic electrocardiographic monitoring of cardiac rehabilitation exercise sessions in coronary artery disease. [2019]

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

Implementing Wearable Sensors for Continuous Assessment of Daytime Heart Rate Response in Inpatient Rehabilitation. [2020]

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

Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. [2016]

10. Canada pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]

11. Egypt pubmed.ncbi.nlm.nih.gov

A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. [2018]

12. England pubmed.ncbi.nlm.nih.gov

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]